UNKNOWN AESCULAP AG INSTRUMENT

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: H6 - CODES UPDATED. INVESTIGATION RESULTS: THE COMPLAINED MEDICAL DEVICE WAS NOT AVAILABLE FOR INVESTIGATION. THE INVESTIGATION WAS BASED UPON EVENT DESCRIPTION. BATCH HISTORY REVIEW: DUE TO THE FACT THAT NO LOT NUMBER WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE COMPLAINED DEVICE IS NOT POSSIBLE. EVEN AFTER FAITHFUL ATTEMPTS FOR RETRIEVAL, NO FURTHER INFORMATION COULD BE RECEIVED. 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, ADDITIONAL MEDICAL INTERVENTION. CONCLUSION/PREVENTIVE MEASURES: DUE TO THE LACK OF DATA AND WITHOUT THE COMPLAINED MEDICAL DEVICE BEING AVAILABLE FOR INVESTIGATION, A CLEAR ROOT CAUSE CANNOT BE DRAWN. IN THE EVENT THAT THE COMPLAINED DEVICE WILL BE PROVIDED FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED. BASED UPON THE INVESTIGATION RESULTS, A CAPA IS NOT REQUIRED.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH AN UNKNOWN AESCULAP INSTRUMENT. ACCORDING TO THE COMPLAINT DESCRIPTION, DURING OPEN REDUCTION AND CAPSULORRHAPHY LEFT HIP WITH ADDUCTOR TENOTOMY, A BLACK SPECK ON X-RAY IMAGING WAS FOUND. THE SCRUB TECHNICIAN NOTED THAT THE TIP OF A NEEDLE DRIVER HAD BEEN CHIPPED. MULTIPLE IRRIGATIONS WERE PERFORMED AND ATTEMPTS TO FIND THE FRAGMENT WERE UNSUCCESSFUL. COMPUTED TOMOGRAPHY (CT) SHOWED A METAL FRAGMENT ANTERIOR TO THE HIP JOINT. THE SURGEON DEEMED IT WAS SAFE TO LET THE PIECE REMAIN IN SITU. NO ADVERSE CONSEQUENCES FOR THE PATIENT WERE REPORTED. 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, ADDITIONAL MEDICAL INTERVENTION. ADDITIONAL INFORMATION WAS NOT PROVIDED BUT HAS BEEN REQUESTED. THE ADVERSE EVENT IS FILED UNDER AESCULAP AG REFERENCE NO. (B)(4).

Additional Manufacturer Narrative

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