DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

Description of Event or Problem

IT WAS REPORTED THAT DEPTH GAUGE F/SCR Ø1.3 - 2 MEAS-RANGE AND DEPTH GAUGE F/SCR Ø2+2.4 MEAS-RANGE UP-T EXPERIENCED FAILURES. THE EVENT INVOLVED THE TIPS BREAKING OFF TWO DEPTH GAUGES AND A THIRD BEING SEVERELY BENT WHILE ATTEMPTING TO FIND THE FAR HOLE DURING A CASE. THE DEVICES WERE SEPARATED INTO TWO OR MORE PIECES, AND THE EVENT WAS IDENTIFIED AS INVOLVING NO PATIENT OR USER IMPACT, WITH NO OBSERVABLE CLINICAL SYMPTOMS OR CHANGES.

Additional Manufacturer Narrative

PRODUCT COMPLAINT#: (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.