Q/CONNECT TWIST DRL 3.2MMX60MM

Additional Manufacturer Narrative

(B)(4) D4 - THIS PRODUCT IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO 00880304384682. G2 - FOREIGN: POLAND. G4 - THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS EXEMPT. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT A TWIST DRILL HAD FRACTURED. THE ISSUE WAS IDENTIFIED OUTSIDE OF A CLINICAL SETTING AND DID NOT OCCUR DURING A SURGICAL PROCEDURE. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; NO FURTHER ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED AT THE TIME OF THIS REPORT.

Additional Manufacturer Narrative

(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D9, G3, G6, H2, H3, H6, H8, H11. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THAT FLUTES ARE WORN FROM PREVIOUS USES. SCRATCHES AND NICKS ARE PRESENT. DEVICE HAS FRACTURED IN THE MIDDLE. BOTH PIECES WERE RETURNED FOR EVALUATION. NO OTHER DAMAGE WAS NOTED. DEVICE HAS AN APPROXIMATE FIELD AGE OF 6.5 YEARS. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATION. COMPLAINTS ARE MONITORED PER COMPLAINT TRENDING PROCESS. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

Description of Event or Problem

NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.