QUINTEX CONSTRAINED SCREW 4.0X16MM

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D4 - BATCH NUMBER. H3, YES, EVALUATION. H4 - PRODUCTION DATE. H6 - CODES UPDATED. INVESTIGATION RESULTS: VISUAL INSPECTION: IN THE FIRST STEP A VISUAL INSPECTION OF THE DEFECTIVE SCREW WAS MADE. HERE IT WAS FOUND THAT BOTH THE LOCKING RING AND THREE OF THE FIVE PETALS ARE MISSING. ABSENT FROM SOME DENTS AND SCRATCHES (SECONDARY DAMAGES, MOST PROBABLY CAUSED BY THE REVISION) THE THREE INVOLVED SCREWS ARE IN A FAULTLESS CONDITION. IN THE NEXT STEP THE PLATE (SC522T) WAS INVESTIGATED. HERE WERE FOUND MATERIAL BULGING AT ONE OF THE HOLES. SIMILAR DEFORMATION WAS FOUND AT THE OPPOSITE SIDE OF THE HOLE AT THE BOTTOM SIDE OF THE HOLE. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR ALL LEADING DEVICE(S) LOT NUMBERS AND THE PRODUCTS FOUND TO BE ACCORDING TO SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THERE ARE NO SIMILAR COMPLAINTS AGAINST THE SAME LOT NUMBER(S) WITH THIS ERROR PATTERN. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS CONSIDERED REPORTABLE FOR THE FOLLOWING REASON - ADVERSE EVENT (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS ADVERSE EVENT WAS BASED ON THE PATIENT HARM, REVISION SURGERY. CONCLUSION/PREVENTIVE MEASURES: BASED ON THE INVESTIGATION AND INFORMATION AVAILABLE, IT IS NOT POSSIBLE TO DETERMINE A DEFINITIVE ROOT CAUSE FOR THE MENTIONED FAILURE /ERROR PATTERNS. THE DEFECTS AT THE SCREW AND THE DEFORMATION AT THE PLATE ARE HINTS, THAT THE SCREW WAS SCREWED IN THE PLATE (AND THE BONE) AT TOO OBLIQUE AN ANGLE. BASED UPON THE INVESTIGATION RESULTS, A CAPA IS NOT REQUIRED.

Description of Event or Problem

INVOLVED COMPONENTS: SC403T - QUINTEX CONSTRAINED SCREW 4.0X16MM (INTERNAL AESCULAP AG REF. NO. (B)(4)). SC522T - QUINTEX HYBRID PLATE 2-LEVEL 37MM (INTERNAL AESCULAP AG REF. NO. (B)(4)).

Additional Manufacturer Narrative

MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE PRODUCT SC403T - QUINTEX CONSTRAINED SCREW 4.0X16MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE SCREW HAS BROKEN POSTOPERATIVELY. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS CONSIDERED REPORTABLE FOR THE FOLLOWING REASON - ADVERSE EVENT (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS ADVERSE EVENT WAS BASED ON THE PATIENT HARM, REVISION SURGERY. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AESCULAP AG REFERENCE NO. (B)(4) . INVOLVED COMPONENTS: SC403T - QUINTEX CONSTRAINED SCREW 4.0X16MM (INTERNAL AESCULAP AG REF. NO. (B)(4). SC522T - QUINTEX HYBRID PLATE 2-LEVEL 37MM (INTERNAL AESCULAP AG REF. NO. (B)(4).