BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDUCTION FORCEPS W/SERRATED JAW-LARGE HANDLE-SOFT RATCHET

    MDR report key: 9013765 · Received September 12, 2019

    Report

    Report Number
    2939274-2019-60508
    Event Type
    Malfunction
    Date Received
    September 12, 2019
    Report Date
    August 14, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTD
    UDI-DI
    10886982202390
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. H10 ADDITIONAL NARRATIVE: H6 - METHOD CODES. H11 CORRECTED DATA: G1 - PHYSICAL MANUFACTURER. 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

    DEVICE RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORD. DEVICE HISTORY LOT: PRODUCT CODE: 399.124. LOT #: 5012708. MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: 10. NOV. 2006. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. INVESTIGATION SUMMARY BACKGROUND: IT WAS REPORTED ON AN UNKNOWN DATE, THE REDUCTION FORCEPS BROKE TOWARDS THE TIP. THE ISSUE WAS DISCOVERED AFTER THE CASE. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. INVESTIGATION FLOW: DAMAGE. VISUAL INSPECTION: THE REDUCTION FORCEPS W/SERRATED JAW-LARGE HANDLE-SOFT RATCHET (P/N 399.124 LOT 5012708) WAS RECEIVED SHOWING ONE OF THE SERRATED JAW TIPS BROKEN OFF. THE BROKEN OFF TIP FRAGMENT WAS NOT RETURNED. NO OTHER ISSUES WERE IDENTIFIED. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS NOT CONDUCTED DUE TO POST MANUFACTURING DAMAGE AND MISSING FRAGMENTS. DOCUMENT/SPECIFICATION REVIEW: THE FOLLOWING DRAWINGS, REFLECTING THE MANUFACTURED AND CURRENT REVISION, WERE REVIEWED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. CONCLUSION: THE COMPLAINT CONDITION IS CONFIRMED FOR THE REDUCTION FORCEPS W/SERRATED JAW-LARGE HANDLE-SOFT RATCHET (P/N 399.124 LOT 5012708) AS ONE OF THE SERRATED JAW TIPS WAS BROKEN OFF. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED, IT IS POSSIBLE THAT THE DEVICE ENCOUNTERED UNINTENDED FORCES AND/OR ROUGH HANDLING. DURING THIS INVESTIGATION NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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 ON AN UNKNOWN DATE, THE REDUCTION FORCEPS BROKE TOWARDS THE TIP. THE ISSUE WAS DISCOVERED AFTER THE CASE. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796320 REDUCTION FORCEPS W/SERRATED JAW-LARGE HANDLE-SOFT RATCHET FORCEPS HTD WRIGHTS LANE SYNTHES USA PRODUCTS LLC 399.124 5012708 10886982202390

    Patients

    Seq Age Sex Outcome Treatment
    1