APTUS

Description of Event or Problem

A CASE IN FRANCE WAS REPORTED TO MEDARTIS AG. AT THE 4-WEEK FOLLOW-UP AFTER THE INITIAL OSTEOSYNTHESIS, A PLATE FRACTURE WAS IDENTIFIED, ALTHOUGH THE PATIENT DID NOT REPORT ANY APPARENT TRAUMA. DURING THE REVISION SURGERY, A SURGICAL SITE INFECTION WAS SUSPECTED. WHILE SUCH INFECTIONS CAN CONTRIBUTE TO HARDWARE FAILURE, IT IS OFTEN DIFFICULT TO DETERMINE THE FULL EXTENT OF THEIR IMPACT. THE REVISION PROCEDURE INCLUDED REMOVAL OF THE PLATE AND SCREWS, INSTRUMENTAL REDUCTION USING FORCEPS, AND OPEN REDUCTION AND INTERNAL FIXATION (ORIF) WITH A NEW PLATE (LCP DEPUY SYNTHES). TIMELINE OF THE CASE: DATE OF SURGERY: ON (B)(6) 2026. DATE OF INCIDENT / FAILURE DETECTION: ON (B)(6) 2026. DATE OF SECOND SURGERY: ON (B)(6) 2026.

Additional Manufacturer Narrative

PROCEDURE: ULNA SHORTENING OSTEOTOMY. (APTUS ULNA SHORTENING / MEDARTIS 2.5). PATIENT SAFETY CHECKLIST COMPLETED IN THE OPERATING ROOM. ANTIBIOTIC PROPHYLAXIS ADMINISTERED ACCORDING TO PROTOCOL. UNDER GENERAL ANESTHESIA, IN THE SUPINE POSITION, WITH AN ARM TABLE. TOURNIQUET INFLATED AT THE BASE OF THE LIMB TO 250 MMHG FOR 63 MINUTES. SWABBING WITH ALCOHOL-BASED BETADINE AND STERILE DRAPING OF THE LIMB. UNDER FLUOROSCOPIC GUIDANCE. SURGICAL APPROACH CENTERED ON THE ULNAR CREST. IDENTIFICATION AND PROTECTION OF THE DORSAL SENSORY BRANCH OF THE ULNAR NERVE OPENING OF THE INTERMUSCULAR SEPTUM BETWEEN THE FUC AND EUC. SUBPERIOSTEAL APPROACH TO THE ULNA. POSITIONING OF THE PLATE (APTUS ULNA SHORTENING (MEDARTIS 2.5 MM)) IN THE PALMAR POSITION AND OF THE CUTTING GUIDE ACCORDING TO THE ANCILLARY DEVICE. PERFORMED AN OBLIQUE OSTEOTOMY USING AN OSCILLATING SAW GUIDED BY A RESECTION GUIDE FOR A TOTAL OF 6 MM. APPLIED COMPRESSION TO THE OSTEOTOMY SITE, THEN PLACED ALL CORTICAL SCREWS, WHICH WERE LOCKED IN PLACE WITH SATISFACTORY STABILITY. SATISFACTORY FLUOROSCOPIC VERIFICATION FROM THE ANTERIOR AND LATERAL VIEWS. COMPLETE PRONOSUPINATION ACHIEVED. THOROUGH IRRIGATION. LAYER-BY-LAYER CLOSURE WITH MONOCRYL 3.0 SUTURES. DRESSING WITH STERI-STRIPS, STERILE GAUZE, AND ADHESIVE TAPE. NORMAL REVASCULARIZATION OF THE FINGERS UPON REMOVAL OF THE TOURNIQUET. IMMOBILIZATION WITH A SPLINT. SATISFACTORY IMMEDIATE POSTOPERATIVE RADIOGRAPHIC FOLLOW-UP. DRESSING: DAY 1. DISCHARGE: OUTPATIENT SURGERY. THE SPLINT SHOULD BE REPLACED ON DAY 1 WITH A CUSTOM-MADE BRACE, WHICH MUST BE WORN CONTINUOUSLY FOR 4 WEEKS AND THEN FOR 2 WEEKS AT NIGHT. REHABILITATION: AS DIRECTED DURING FOLLOW-UP VISITS. FOLLOW-UP APPOINTMENT WITH DR. (B)(6) IN 15 DAYS, WITH DRESSING CHANGE AND FOLLOW-UP X-RAYS. ON (B)(6) 2026: FOLLOW-UP SURGERY: DIAGNOSIS(ES): SURGICAL SITE INFECTION FOLLOWING A SHORTENING OSTEOTOMY OF THE LEFT ULNA. AT THE 1-MONTH FOLLOW-UP VISIT: FRACTURE OF THE PLATE WITH DISPLACEMENT OF THE OSTEOTOMY SITE. INDICATIONS FOR REVISION SURGERY. PROCEDURE TITLE: REMOVAL OF FOREIGN MATERIAL FROM THE LEFT ULNA - BONE DEBRIDEMENT - IRRIGATION - FIXATION WITH A 3.5 MM LCP PLATE (SYNTHES). SURGICAL PROTOCOL: AFTER COMPLETING THE 2018 HAS CHECKLIST. GENERAL ANESTHESIA (GA) WITH REGIONAL ANESTHESIA (RA) VIA ULTRASOUND-GUIDED PLEXUS BLOCK. PATIENT POSITIONED IN THE SUPINE POSITION ON A TABLE WITH ADJUSTABLE ARMS. TOURNIQUET APPLIED AT THE BASE OF THE LIMB AT 250 MMHG FOR 91 MINUTES. STERILE CLEANSING, SWABBING, AND DRAPING ACCORDING TO PROTOCOL. REOPENING OF THE SURGICAL APPROACH WITH EXCISION OF A SUSPICIOUS-LOOKING AREA OF SKIN. TRANSITION FROM FUC TO EUC. IDENTIFICATION OF FALSE MEMBRANES AND TISSUE WITH AN INFECTED APPEARANCE. EXPOSURE AND REMOVAL OF THE PLATE. BONE DEBRIDEMENT AND EXCISION OF ALL TISSUE WITH AN INFECTED APPEARANCE. THREE BACTERIAL CULTURES WERE OBTAINED (2 BONE AND 1 SOFT TISSUE). EXTENSIVE IRRIGATION WITH SALINE SOLUTION AND A 3L PULSED KARCHER. OSTEOSYNTHESIS OF THE OSTEOTOMY BY PLACEMENT OF A 3.5MM 7-HOLE LCP (SYNTHES) PLATE, USING ALTERNATING CORTICAL AND LOCKING SCREWS. STABLE FIXATION. SATISFACTORY FLUOROSCOPIC VIEWS FROM THE FRONT AND SIDE. THOROUGH IRRIGATION WITH SALINE SOLUTION. SUBCUTANEOUS CLOSURE WITH 3.0 MONOCRYL AND 3.0 SUTURE THREAD TO THE SKIN OVER A REDON DRAIN. DRY DRESSING. GOOD RETURN OF COLOR TO THE FINGERS UPON RELEASE OF THE TOURNIQUET. BABP SPLINT. POSTOPERATIVE INSTRUCTIONS: IMMOBILIZATION USING A THERMOFORMED BRACE FOR 6 WEEKS. ANTIBIOTIC THERAPY TO BE CONTINUED BASED ON ANTIBIOTIC SUSCEPTIBILITY TESTING. REMOVAL OF THE REDON DRAIN ON DAY 2.

Description of Event or Problem

A CASE IN FRANCE WAS REPORTED TO MEDARTIS AG. AT THE 4-WEEK FOLLOW-UP AFTER THE INITIAL OSTEOSYNTHESIS, A PLATE FRACTURE WAS IDENTIFIED, ALTHOUGH THE PATIENT DID NOT REPORT ANY APPARENT TRAUMA. DURING THE REVISION SURGERY, A SURGICAL SITE INFECTION WAS SUSPECTED. WHILE SUCH INFECTIONS CAN CONTRIBUTE TO HARDWARE FAILURE, IT IS OFTEN DIFFICULT TO DETERMINE THE FULL EXTENT OF THEIR IMPACT. THE REVISION PROCEDURE INCLUDED REMOVAL OF THE PLATE AND SCREWS, INSTRUMENTAL REDUCTION USING FORCEPS, AND OPEN REDUCTION AND INTERNAL FIXATION (ORIF) WITH A NEW PLATE (LCP DEPUY SYNTHES). TIMELINE OF THE CASE: DATE OF SURGERY: (B)(6) 2026. DATE OF INCIDENT / FAILURE DETECTION: (B)(6) 2026. DATE OF SECOND SURGERY: (B)(6) 2026.

Additional Manufacturer Narrative

PROCEDURE: ULNA SHORTENING OSTEOTOMY (APTUS ULNA SHORTENING / MEDARTIS 2.5) PATIENT SAFETY CHECKLIST COMPLETED IN THE OPERATING ROOM. ANTIBIOTIC PROPHYLAXIS ADMINISTERED ACCORDING TO PROTOCOL. UNDER GENERAL ANESTHESIA, IN THE SUPINE POSITION, WITH AN ARM TABLE. TOURNIQUET INFLATED AT THE BASE OF THE LIMB TO 250 MMHG FOR 63MINUTES. SWABBING WITH ALCOHOL-BASED BETADINE AND STERILE DRAPING OF THELIMB. UNDER FLUOROSCOPIC GUIDANCE. SURGICAL APPROACH CENTERED ON THE ULNAR CREST. IDENTIFICATION AND PROTECTION OF THE DORSAL SENSORY BRANCH OF THE ULNAR NERVE OPENING OF THE INTERMUSCULAR SEPTUM BETWEEN THE FUC AND EUC. SUBPERIOSTEAL APPROACH TO THE ULNA. POSITIONING OF THE PLATE (APTUS ULNA SHORTENING (MEDARTIS 2.5 MM)) IN THE PALMAR POSITION AND OF THE CUTTING GUIDE ACCORDING TO THE ANCILLARY DEVICE. PERFORMED AN OBLIQUE OSTEOTOMY USING AN OSCILLATING SAW GUIDED BY A RESECTION GUIDE FOR A TOTAL OF 6 MM. APPLIED COMPRESSION TO THE OSTEOTOMY SITE, THEN PLACED ALL CORTICAL SCREWS, WHICH WERE LOCKED IN PLACE WITH SATISFACTORY STABILITY. SATISFACTORY FLUOROSCOPIC VERIFICATION FROM THE ANTERIOR AND LATERAL VIEWS. COMPLETE PRONOSUPINATION ACHIEVED. THOROUGH IRRIGATION. LAYER-BY-LAYER CLOSURE WITH MONOCRYL 3.0 SUTURES. DRESSING WITH STERI-STRIPS, STERILE GAUZE, AND ADHESIVE TAPE. NORMAL REVASCULARIZATION OF THE FINGERS UPON REMOVAL OF THE TOURNIQUET. IMMOBILIZATION WITH A SPLINT. SATISFACTORY IMMEDIATE POSTOPERATIVE RADIOGRAPHIC FOLLOW-UP. DRESSING: DAY 1 DISCHARGE: OUTPATIENT SURGERY THE SPLINT SHOULD BE REPLACED ON DAY 1 WITH A CUSTOM-MADE BRACE, WHICH MUST BE WORN CONTINUOUSLY FOR 4 WEEKS AND THEN FOR 2 WEEKS AT NIGHT. REHABILITATION: AS DIRECTED DURING FOLLOW-UP VISITS FOLLOW-UP APPOINTMENT WITH DR. NGUYEN IN 15 DAYS, WITH DRESSING CHANGE AND FOLLOW-UP X-RAYS 10.02.2026: FOLLOW-UP SURGERY DIAGNOSIS(ES): SURGICAL SITE INFECTION FOLLOWING A SHORTENING OSTEOTOMY OF THE LEFT ULNA AT THE 1-MONTH FOLLOW-UP VISIT: FRACTURE OF THE PLATE WITH DISPLACEMENT OF THE OSTEOTOMY SITE. INDICATIONS FOR REVISION SURGERY. PROCEDURE TITLE: REMOVAL OF FOREIGN MATERIAL FROM THE LEFT ULNA - BONE DEBRIDEMENT - IRRIGATION - FIXATION WITH A 3.5 MM LCP PLATE (SYNTHES) SURGICAL PROTOCOL: AFTER COMPLETING THE 2018 HAS CHECKLIST. GENERAL ANESTHESIA (GA) WITH REGIONAL ANESTHESIA (RA) VIA ULTRASOUND-GUIDED PLEXUS BLOCK PATIENT POSITIONED IN THE SUPINE POSITION ON A TABLE WITH ADJUSTABLE ARMS TOURNIQUET APPLIED AT THE BASE OF THE LIMB AT 250 MMHG FOR 91 MINUTES STERILE CLEANSING, SWABBING, AND DRAPING ACCORDING TO PROTOCOL REOPENING OF THE SURGICAL APPROACH WITH EXCISION OF A SUSPICIOUS-LOOKING AREA OF SKIN. TRANSITION FROM FUC TO EUC. IDENTIFICATION OF FALSE MEMBRANES AND TISSUE WITH AN INFECTED APPEARANCE. EXPOSURE AND REMOVAL OF THE PLATE. BONE DEBRIDEMENT AND EXCISION OF ALL TISSUE WITH AN INFECTED APPEARANCE. THREE BACTERIAL CULTURES WERE OBTAINED (2 BONE AND 1 SOFT TISSUE). EXTENSIVE IRRIGATION WITH SALINE SOLUTION AND A 3L PULSED KARCHER. OSTEOSYNTHESIS OF THE OSTEOTOMY BY PLACEMENT OF A 3.5MM 7-HOLE LCP (SYNTHES) PLATE, USING ALTERNATING CORTICAL AND LOCKING SCREWS. STABLE FIXATION. SATISFACTORY FLUOROSCOPIC VIEWS FROM THE FRONT AND SIDE. THOROUGH IRRIGATION WITH SALINE SOLUTION. SUBCUTANEOUS CLOSURE WITH 3.0 MONOCRYL AND 3.0 SUTURE THREAD TO THE SKIN OVER A REDON DRAIN. DRY DRESSING. GOOD RETURN OF COLOR TO THE FINGERS UPON RELEASE OF THE TOURNIQUET. BABP SPLINT. POSTOPERATIVE INSTRUCTIONS: IMMOBILIZATION USING A THERMOFORMED BRACE FOR 6 WEEKS. ANTIBIOTIC THERAPY TO BE CONTINUED BASED ON ANTIBIOTIC SUSCEPTIBILITY TESTING. REMOVAL OF THE REDON DRAIN ON DAY 2.