PERIOSTEAL ELEVATOR 3MM CURVED BLADE-STRAIGHT EDGE

Additional Manufacturer Narrative

DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE PERIOSTEAL ELEVATOR 3MM CURVED BLADE-STRAIGHT EDGE (P/N: 399.48, LOT NUMBER: T197773) WAS RECEIVED AT US CQ. VISUAL INSPECTION OF THE COMPLAINT DEVICE SHOWED NO DAMAGE TO THE DEVICES. A REVIEW OF THE DESIGN DRAWING FOUND NO MENTION OF SANDBLASTING, BEAD BLASTING, OR SIMILAR METHODS. DIMENSIONAL INSPECTION: A DIMENSIONAL INSPECTION WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. DOCUMENT/SPECIFICATION REVIEW: RELEVANT DRAWINGS WERE REVIEWED. NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. INVESTIGATION CONCLUSION: THIS COMPLAINT IS NOT CONFIRMED AS THERE IS NO MENTION OF SANDBLASTING OR OTHER BLASTING IN THE DESIGN DRAWINGS AND THE COMPLAINT DEVICE HAS NO DAMAGE. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART NUMBER: 399.48, LOT NUMBER: T197773, MANUFACTURING SITE: TUTTLINGEN, RELEASE TO WAREHOUSE DATE: 24-JUN-2020. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Additional Manufacturer Narrative

THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CUSTOMER BOUGHT TWO (2) PERIOSTEAL ELEVATORS. WHEN THEY RECEIVED THE INSTRUMENTS, BOTH INSTRUMENTS SEEMED TO HAVE BEEN SANDBLASTED ON THE HANDLE AND THE STERILIZATION DEPARTMENT REFUSED TO PROCESS THEM. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) PERIOSTEAL ELEVATOR 3MM CURVED BLADE-STRAIGHT EDGE. THIS IS REPORT 1 OF 2 FOR (B)(4).