BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANT HOLDER-SLOT

    MDR report key: 12806397 · Received November 12, 2021

    Report

    Report Number
    2939274-2021-06684
    Event Type
    Malfunction
    Date Received
    November 12, 2021
    Report Date
    October 19, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTD
    UDI-DI
    10705034778211
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. H6 - CODES UPDATED TO IMDRF CODES. VISUAL INSPECTION: THE COMPLAINT DEVICE IMPLANT HOLDER-SLOT(PRODUCT CODE: 397.011, LOT NUMBER: 0041596) WAS RETURNED TO CQ WEST CHESTER FOR INVESTIGATION. THE SCREW ON THE HANDLE WAS FOUND SEPARATED FROM THE REST OF THE IMPLANT HOLDER AND THE PIN THAT HOLDS THE SCREW TO THE HANDLE WAS MISSING. THE PART WAS DISCOLORED AND SHOWED SIGNS OF CORROSION ON ITS SURFACE. DOCUMENT/SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE, THE CURRENT AND THE MANUFACTURED REVISION OF DRAWINGS FOR THE PART WERE REVIEWED. IMPLANT HOLDER SLOT, 397_011 REV J (CURRENT) AND REV E(MANUFACTURED) DIMENSIONAL INSPECTION: A DIMENSIONAL INSPECTION WAS DEEMED IRRELEVANT AS THE ISSUE WAS IDENTIFIED TO BE DUE TO THE PIN MISSING FROM THE HANDLE. CONCLUSION: THE ITEM WAS MISSING A COMPONENT LEADING TO THE DISASSEMBLING OF THE SCREW FROM THE HANDLE. A DEFINITIVE ASSIGNABLE ROOT CAUSE CANNOT BE IDENTIFIED FROM THE AVAILABLE 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. DEVICE HISTORY LOT - NO NCRS WERE GENERATED DURING PRODUCTION. DEVICE HISTORY REVIEW - 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, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT, DURING THE REVERSE LOGISTICS AUDIT OF THE RETURNED DEVICE AT (B)(4) THE IMPLANT HOLDER SLOT WAS FOUND BROKEN. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) IMPLANT HOLDER-SLOT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1700968 IMPLANT HOLDER-SLOT FORCEPS HTD WRIGHTS LANE SYNTHES USA PRODUCTS LLC 397.011 0041596 10705034778211

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown