BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM

    MDR report key: 13487665 · Received February 8, 2022

    Report

    Report Number
    2939274-2022-00397
    Event Type
    Malfunction
    Date Received
    February 8, 2022
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTD
    UDI-DI
    10886982203175
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTER IS A J&J EMPLOYEE. A PRODUCT INVESTIGATION WAS CONDUCTED. THE PRODUCT WAS RETURNED TO DEPUY SYNTHES CQ FOR EVALUATION. THE DEPUY SYNTHES CQ TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE RED FORCEPS SERRATED JAW-RATCHET 144 WAS BROKEN, AND BROKEN PIECE WAS NOT RETURNED. NO OTHER ISSUES WERE IDENTIFIED. THE DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO THE GEOMETRY OF THE DEVICE. THE OBSERVED CONDITION ON THE DEVICE WAS CONSISTENT WITH A RANDOM COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO UNINTENDED FORCES. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED AS THE RED FORCEPS SERRATED JAW-RATCHET 144 WAS OBSERVED TO BE BROKEN. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED, IT IS PROBABLE THAT THE RED FORCEPS SERRATED JAW-RATCHET 144 WAS BROKEN DUE TO UNINTENDED FORCES. 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: 399.99; LOT NUMBER: T170329. MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: 22-AUG-2018. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE RAW MATERIAL CERTIFICATE WAS REVIEWED AND THE USED MATERIAL WAS ACCORDING TO THE SPECIFICATION OF THE DEVICE. 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 ON UNKNOWN DATE, DURING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE RED FORCEPS SERRATED JAW-RATCHET 144 WAS BROKEN. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903418 REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM FORCEPS HTD WRIGHTS LANE SYNTHES USA PRODUCTS LLC 399.99 T170329 10886982203175

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown