BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTION SCREW FOR TI FEMORAL AND TIBIAL NAILS

    MDR report key: 12110780 · Received July 2, 2021

    Report

    Report Number
    2939274-2021-03387
    Event Type
    Malfunction
    Date Received
    July 2, 2021
    Report Date
    June 11, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWB
    UDI-DI
    10886982195883
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE EXTRACTION SCR FOR TI FEM & TIB NAIL (PART #: 357.133, LOT # 3200851) WAS RECEIVED AT US CQ. UPON VISUAL INSPECTION AT CQ, IT IS OBSERVED THAT THE THREADED PART OF THE DEVICE WAS STRIPPED. THE REST OF THE DEVICE LOOKS GOOD WITH MINIMAL WEAR WITHOUT ANY PHYSICAL DAMAGE CONSISTENT WITH THE USAGE OF THE DEVICE. DIMENSIONAL INSPECTION: NO DIMENSIONAL INSPECTION CAN BE PERFORMED DUE TO POST-MANUFACTURING DAMAGE. DOCUMENTATION/ SPECIFICATION REVIEW: THE RELEVANT DRAWING(S) WAS REVIEWED; NO DESIGN ISSUES OR DISCREPANCIES WERE FOUND DURING THIS INVESTIGATION. INVESTIGATION CONCLUSION: THE OVERALL COMPLAINT WAS CONFIRMED AS THE DEVICE WAS STRIPPED. HOWEVER, NO BROKEN FEATURES WERE OBSERVED. NO DEFINITIVE ROOT CAUSE CAN BE DETERMINED BASED ON THE PROVIDED INFORMATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. 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 # 357.133. SYNTHES LOT # 3200851 . SUPPLIER LOT # 3200851 . RELEASE TO WAREHOUSE DATE: 03 JUL 2009. SUPPLIER: HAGENDORF. NO NCR'S WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. H10 ADDITIONAL NARRATIVE: D4: UPDATED LOT NUMBER AND EXPIRATION DATE G1: UPDATED 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 · 0

    THERE WERE NO PATIENT AND SURGICAL INVOLVEMENT REPORTED.

    Additional Manufacturer Narrative · 1

    REPORTER IS A J&J EMPLOYEE. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 · 1

    IT WAS REPORTED THAT, DURING THE ROUTINE INCOMING INSPECTION OF A LOANER SET AT FSL UPS MALDEN, MA SITE, AN EXTRACTION SCREW WAS OBSERVED TO BE BROKEN. THIS REPORT IS FOR (1) EXTRACTION SCREW FOR TI FEMORAL AND TIBIAL NAILS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1004201 EXTRACTION SCREW FOR TI FEMORAL AND TIBIAL NAILS EXTRACTOR HWB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 357.133 3200851 10886982195883

    Patients

    Seq Age Sex Outcome Treatment
    1