TWIST DR 25X95MM CANN 12MM THD 30MM AO

Additional Manufacturer Narrative

WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICE, THE DEVICE HISTORY RECORD WERE REVIEWED AND FOUND TO BE CONFORMING. THE DEVICE IS IN TRANSIT TO ZIMMER (B)(4) AND WILL BE INVESTIGATED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION AND INVESTIGATION RESULTS BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. (B)(4).

Description of Event or Problem

IT WAS REPORTED, DURING KIT INSPECTION IT WAS RECOGNIZED THAT THE CANNULATED DRILL DID NOT DRILL THE CANNULATION AS INTENDED. NOTES: THE IMPLANTATION AND EXPLANTATION DATES ARE LEFT EMPTY AS THE DEVICE INVOLVED IN THIS COMPLAINT IS AN INSTRUMENT. HENCE, NO EXPIRATION DATE IS CAPTURED, FOR THE SAME REASON.

Additional Manufacturer Narrative

IT WAS REPORTED, DURING KIT INSPECTION IT WAS RECOGNIZED THAT THE CANNULATED DRILL DID NOT DRILL THE CANNULATION AS INTENDED. NO TREND IDENTIFIED. THE COMPATIBILITY CHECK COULD NOT BE PERFORMED AS ONLY ONE PRODUCT WAS REPORTED TO US. THE PRODUCT COMPATIBILITY CHECK IS NOT RELEVANT FOR ONE PRODUCT ONLY. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. THE TWO CANNULATED TWIST DRILLS WERE RETURNED FOR INVESTIGATION. THE VISUAL EXAMINATION SHOWED NO ABNORMALITIES ON THE OUTER SIDE OF THE DEVICE. THE INNER DIAMETER (CANNULATION) IS COMPLETELY DRILLED THROUGH THE DEVICE AND DID NOT SHOW ANY CONSPICUOUSNESS BY VISUAL EXAMINATION. A FUNCTIONAL TEST WAS PERFORMED, BOTH CANNULATED DRILLS WERE TESTED WITH TEST PINS. THE RESULTS OF THE FUNCTIONAL TEST ARE AS FOLLOWING: THE TEST PIN WITH DIAMETER 1.2MM DID NOT PASS IN THE CANNULATION OF BOTH DEVICES. A SMALLER DIAMETER TEST PIN (1.15MM) WAS TESTED. THIS TEST PIN JUST PASSED IN THE CANNULATION. THIS CONFIRMED THAT THE CANNULATION IS COMPLETE, BUT TOO SMALL FOR THE 1.2 K-WIRE. POSSIBLE CAUSES FOR THE REPORTED EVENT ACCORDING TO RMW: A. WIRE DOES NOT PASS THROUGH THE DEVICE DUE TO FAILURE OF INSTRUMENT MATING CONDITION. B. WIRE DOES NOT PASS THROUGH THE DEVICE DUE TO INADEQUATE DESIGN FOR INTENDED HANDLING PERFORMANCE. COMPARISON TO INVESTIGATION RESULTS WHETHER IT IS POSSIBLE AND JUSTIFICATION: A. POSSIBLE: THE FUNCTIONAL TEST SHOWED THAT IT WAS NOT POSSIBLE TO INSERT THE APPROPRIATE 1.2 K-WIRE THROUGH THE DEVICE. B. POSSIBLE: THE FUNCTIONAL TESTS EVIDENCED THAT THE CANNULATION IS COMPLETE, BUT TOO SMALL FOR THE 1.2 DIAMETER PINS.. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE COULD IDENTIFY A ROOT CAUSE FOR THIS ISSUE. THE CANNULATION OF THE DEVICE IS SMALLER THAN 1.2MM. AN ISSUE INVESTIGATION HAS BEEN INITIATED. THE NEED FOR CORRECTIVE ACTIONS IS NOT INDICATED AT THIS POINT OF TIME AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).