ACCULAN 3TI DRILL ATTACHM.HUDSON/ZIMMER

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B3 - DATE OF EVENT. B5 - DESCRIPTION UPDATED.

Description of Event or Problem

UPDATE: THE SURGERY WAS IMPLANTATION OF A CEMENTED KNEE PROSTHESIS (K-TEP) LEFT KNEE WITH "RPE". FRAGMENTS DID NOT FALL DIRECTLY INTO THE PATIENT BUT IN THE IMMEDIATE VICINITY ON THE STERILE DRAPED AREA. THERE WAS A DELAY AS THE STERILE FIELD WAS RE-DRAPED, AND THE SITE WAS RINSED SEVERAL TIMES.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH GB630R - ACCULAN 3TI DRILL ATTACHM.HUDSON/ZIMMER. ACCORDING TO THE COMPLAINT DESCRIPTION, THE ATTACHMENT OF THE DRILL CAME LOOSE, CAUSING SMALL PARTS TO FALL OFF. THIS OCCURRED WHEN REMOVING A PIN. 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 - MALFUNCTION (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS MALFUNCTION WAS BASED ON REVIEW OF THE APPLICABLE RISK ANALYSIS. ADDITIONAL INFORMATION WAS NOT PROVIDED. THE MALFUNCTION 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.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5 - DESCRIPTION UPDATED D9 - PRODUCT RECEIPT H3 - YES, EVALUATION H6 - CODES UPDATED INVESTIGATION FINDINGS: THE PRODUCT ARRIVED PARTIALLY DISASSEMBLED. VISUAL INSPECTION: THE FOLLOWING DEFECTS WERE OBSERVED: - IMPACT MARKS ON THE COLLET - SPRAY ADAPTER DOES NOT FIT IN DRIVER, DRIVE SHAFT - BENT TIPS ON DRIVE SHAFT - BALL BEARINGS RUN HEAVILY - FRICTION MARKS ON THE GUIDE RING AND ON THE HOUSING. BATCH HISTORY REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN CHECKED FOR ALL LEADING DEVICE(S) LOT NUMBERS AND THE PRODUCTS FOUND TO BE ACCORDING TO SPECIFICATION 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 - MALFUNCTION (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS MALFUNCTION WAS BASED ON REVIEW OF THE APPLICABLE RISK ANALYSIS. CONCLUSION/PREVENTIVE MEASURES: THE FAILURE REPORTED BY THE CUSTOMER HAS BEEN CONFIRMED. THE EXACT ROOT CAUSE CANNOT BE DETERMINED. THE PRODUCT IS OUT OF WARRANTY, AND THE MAINTENANCE DATE HAS PASSED AND WAS NOT OBSERVED (MAINTENANCE DATE 10.2019). EXCERPT OF INSTRUCTIONS FOR USE (IFU)(AESCULAP AG REFERENCE NO. (B)(4)): " TO ENSURE RELIABLE OPERATION, THE PRODUCT MUST BE MAINTAINED AS INDICATED ON THE MAINTENANCE LABEL ONCE PER YEAR." BASED UPON THE INVESTIGATION RESULTS, A CAPA IS NOT REQUIRED.

Description of Event or Problem

UPDATE: TOTAL SURGICAL DELAY OF APPROXIMATELY 15-20 MINUTES.