BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM

    MDR report key: 9210016 · Received October 18, 2019

    Report

    Report Number
    2939274-2019-61664
    Event Type
    Malfunction
    Date Received
    October 18, 2019
    Report Date
    October 2, 2019
    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
    MI, 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. PART: 399.99. LOT: A7DA019. MANUFACTURING SITE: TUTTLINGEN. RELEASE TO WAREHOUSE DATE: WEEK 19, 1994. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) IS NOT POSSIBLE; THE DHR IS NO LONGER AVAILABLE DUE TO THE AGE OF THE INSTRUMENT (OVER 24 YEARS OLD). VISUAL INSPECTION: THE REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144 MM WAS RECEIVED AT US CQ WITH ONE OF THE JAWS BROKEN OFF OF THE RATCHET. THIS IS CONSISTENT WITH THE REPORTED COMPLAINT CONDITION, THUS CONFIRMING THE COMPLAINT. THE RATCHET WAS ALSO FOUND TO BE LOOSE WHEN OPENING AND CLOSING. DIMENSIONAL INSPECTION: DIMENSIONAL ANALYSIS WAS NOT PERFORMED DUE TO POST MANUFACTURING DAMAGE. DOCUMENT/SPECIFICATION REVIEW: THE FOLLOWING DRAWING(S) WAS REVIEWED; REDUCTION FORCEPS WITH SERRATED JAW. REDUCTION FORCEPS WITH SERRATED JAW. THE OLDEST AVAILABLE DRAWING FOR REVIEW WAS RELEASED ON MARCH 16, 1995. CONCLUSION: THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED, IT IS POSSIBLE THAT THE DEVICE ENCOUNTERED UNINTENDED FORCES OVER THE 24+ YEAR LIFETIME OF THE DEVICE. NO NEW MALFUNCTIONS WERE OBSERVED DURING THE COURSE OF THIS INVESTIGATION. 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. 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, THE REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM WAS BROKEN. IT WAS RECENTLY BOUGHT AND RECENTLY SNAPPED LIKE THE SERRATED END OF IT. THE PIECE SNAP RIGHT OF IT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1005185 REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM FORCEPS HTD WRIGHTS LANE SYNTHES USA PRODUCTS LLC 399.99 A7DA019 10886982203175

    Patients

    Seq Age Sex Outcome Treatment
    1