LARGE-DISTRACT CPL

Additional Manufacturer Narrative

510K: THIS REPORT IS FOR AN UNKNOWN DISTRACTOR UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: CHEN M., ET AL (2021)LATERAL DISTRACTOR USE DURING INTERNAL FIXATION OF TIBIAL PLATEAU FRACTURES HAS A MINIMAL RISK OF IATROGENIC PERONEAL NERVE PALSY, JOURNAL OF ORTHOP TRAUMA, VOLUME 35:PAGES E51¿E55 (USA). THIS STUDY AIMS TO DETERMINE THE APPLICATION OF AN INTRAOPERATIVE LATERAL DISTRACTOR FOR VISUALIZATION AND REDUCTION OF THE LATERAL TIBIAL PLATEAU IS SAFE AND POSES A MINIMAL RISK FOR IATROGENIC PERONEAL NERVE INJURY. OVER THE LAST 10 YEARS, ALL PATIENTS WHO HAD TIBIAL PLATEAU FRACTURES (TPFS) AND UNDERWENT ORIF WERE IDENTIFIED.A TOTAL OF 147 PATIENTS (81 FEMALES,66 MALES) WITH MEAN AGE OF 52 YEARS THAT RECEIVED INTRAOPERATIVE APPLICATION OF A LATERAL DISTRACTOR WERE INCLUDED IN THE STUDY. FIXATION WAS DONE USING A 5.0-MM SELF-TAPPING SCHANZ PINS (SYNTHES, PAOLI, PA) AND LARGE UNIVERSAL DISTRACTOR (SYNTHES) WERE USED. STAGED EXTERNAL FIXATION WAS PERFORMED IN 23 PATIENTS, AND THE REST WERE TREATED WITH IMMEDIATE ORIF. THE STATUS OF THE PERONEAL NERVE WAS DETERMINED USING CLINICAL DOCUMENTATION FROM THE PREOPERATIVE SETTING, INPATIENT POSTOPERATIVE SETTING, AND THE FIRST 2-WEEK CLINIC FOLLOW-UP VISIT. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: PATIENT 1 ,HAD PERONEAL NERVE DEFICITS HAD ISOLATED PARTIAL SENSORY DEFICITS IN THE DEEP PERONEAL NERVE DISTRIBUTION THAT RESOLVED 12 WEEKS POSTOPERATIVE. PATIENT 2, HAD ISOLATED PARTIAL MOTOR DEFICITS OF THE TIBIALIS ANTERIOR AND EXTENSOR HALLUCIS LONGUS MUSCLES THAT WERE LESS THAN ANTIGRAVITY STRENGTH (PATIENT 2).THIS PATIENT WAS TREATED WITH AN ANKLE-FOOT ORTHOSIS TO PREVENT AN EQUINUS CONTRACTURE AND WAS LOST TO FOLLOW-UP AFTER THE 2-WEEK POSTOPERATIVE VISIT. THE ONLY PATIENT WITH POSTOPERATIVE PERONEAL NERVE MOTOR DYSFUNCTION. PATIENT 3, HAD PERONEAL NERVE DEFICITS HAD ISOLATED PARTIAL SENSORY DEFICITS IN THE DEEP PERONEAL NERVE DISTRIBUTION THAT RESOLVED 12 WEEKS POSTOPERATIVE. THE REST OF THE 144 PATIENTS ONLY HAD TEMPORARY PERONEAL NERVE MOTOR AND/OR SENSORY DEFICITS IN THE SETTING OF A PERIPHERAL NERVE BLOCK THAT RESOLVED COMPLETELY AFTER THE ANESTHETIC WORE OFF. THIS REPORT IS FOR AN UNKNOWN SYNTHES LARGE UNIVERSAL DISTRACTOR . THIS IS REPORT 1 OF 4 FOR (B)(4).