BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE HOLDING FORCEPS-SOFT RATCHET F/PLATES TO 9MM WIDE

    MDR report key: 11113360 · Received January 4, 2021

    Report

    Report Number
    2939274-2021-00024
    Event Type
    Malfunction
    Date Received
    January 4, 2021
    Report Date
    December 8, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTD
    UDI-DI
    10886982202314
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. INVESTIGATION FLOW: DAMAGE. VISUAL INSPECTION: THE BONE HOLDING FORCEPS-SOFT RATCHET F/PLATES TO 9MM WIDE (P/N: 399.091, LOT #: 5905177) WAS RETURNED AND RECEIVED AT US CQ. UPON VISUAL INSPECTION, THE RATCHETING MECHANISM WAS SLIGHTLY STIFF BUT HAVE NO IMPACT ON THE DEVICE FUNCTIONALITY. NO OTHER ISSUES WERE OBSERVED WITH THE DEVICE RETURNED. DEVICE FAILURE/DEFECT WAS IDENTIFIED. SERVICE AND REPAIR EVALUATION: THE CUSTOMER REPORTED THE DEVICE WAS BROKEN. DAMAGED COMPONENT IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE PER THE INSPECTION SHEET. THE CAUSE OF THE ISSUE IS UNKNOWN. THE ITEM WILL BE FORWARDED TO CUSTOMER QUALITY. THE EVALUATION WAS CONFIRMED. DIMENSIONAL INSPECTION: A DIMENSIONAL INSPECTION WAS NOT PERFORMED AS THERE WAS BROKEN CONDITION OBSERVED WITH THE RETURNED DEVICE. DOCUMENT/SPECIFICATION REVIEW BASED ON THE DATE OF MANUFACTURE, THE CURRENT AND MANUFACTURED REVISION OF DRAWINGS WERE REVIEWED. THE COMPLAINT WAS NOT CONFIRMED. INVESTIGATION CONCLUSION: THE COMPLAINT CONDITION WAS NOT CONFIRMED FOR THE BONE HOLDING FORCEPS-SOFT RATCHET F/PLATES TO 9MM WIDE (P/N: 399.091, LOT #: 5905177). THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. 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. PRODUCT CODE: 399.091. LOT NUMBER: 5905177. MANUFACTURING SITE: SALZBURG. RELEASE TO WAREHOUSE DATE: MAR. 10, 2010. A MANUFACTURING RECORD EVALUATION 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 · 1

    REPORTER IS A SYNTHES EMPLOYEE. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 ON AN UNKNOWN DATE DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, THE BONE HOLDING FORCEPS - SOFT RATCHET F/PLATES TO 9MM WIDE WAS BROKEN. THERE WAS NO PATIENT AND SURGICAL INVOLVEMENT. THIS REPORT IS FOR 1 BONE HOLDING FORCEPS-SOFT RATCHET F/PLATES TO 9MM WIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5004 BONE HOLDING FORCEPS-SOFT RATCHET F/PLATES TO 9MM WIDE HTD HTD WRIGHTS LANE SYNTHES USA PRODUCTS LLC 399.091 5905177 10886982202314

    Patients

    Seq Age Sex Outcome Treatment
    1