BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM

    MDR report key: 8438011 · Received March 20, 2019

    Report

    Report Number
    2939274-2019-57059
    Event Type
    Malfunction
    Date Received
    March 20, 2019
    Report Date
    February 22, 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
    TN, 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: H3, H4, H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART NUMBER: 399.99, LOT NUMBER: A7DA21, MANUFACTURING SITE: TUTTLINGEN, RELEASE TO WAREHOUSE DATE: WEEK 21, 1994. A MANUFACTURING RECORD EVALUATION IS NOT POSSIBLE, THE DHR IS NO LONGER AVAILABLE DUE TO THE AGE OF THE INSTRUMENT (OVER 24 YEARS OLD). H3, H6: A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: VISUAL INSPECTION PERFORMED AT CUSTOMER QUALITY (CQ) CONFIRMED THE CONDITION OF DEVICE BREAKAGE, WHICH AGREES WITH THE REPORTED COMPLAINT CONDITION.ONE OF THE JAW HAS BEEN BROKEN FROM 4TH TEETH OF PROXIMAL SIDE. BROKEN PORTION HAS NOT BEEN RECEIVED AT THE US CUSTOMER QUALITY(CQ). DOCUMENT REVIEW: RELEVANT DRAWINGS WERE REVIEWED DURING INVESTIGATION: NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. DIMENSIONAL ANALYSIS: A RELEVANT DIMENSIONAL INSPECTION WAS NOT ABLE TO BE PERFORMED AT CQ BECAUSE THE SHEARED OFF DISTAL JAW PORTION WAS NOT RETURNED. MATERIAL ANALYSIS: DUE TO AGE, THERE IS NO INDICATION THAT MATERIAL PROPERTIES OR DIMENSIONS POSSIBLY WOULD HAVE CONTRIBUTED TO THE RETURNED 24+ YEAR OLD DEVICE WITH A BROKEN JAW. CONCLUSION: THIS COMPLAINT IS CONFIRMED HOWEVER NO PRODUCT DESIGN ISSUES OR MANUFACTURING DISCREPANCIES THAT WOULD CONTRIBUTE TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED DURING THIS INVESTIGATION. THE MOST LIKELY CAUSE FOR THIS COMPLAINT IS ROUGH HANDLING, AS PER THE COMPLAINT DESCRIPTION "REDUCTION FORCEPS WAS BROKEN DURING POST MANUFACTURING INCIDENT". BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. H11 CORRECTED DATA: D10. 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

    OCCUPATION: INITIAL REPORTER IS SYNTHES SALES REPRESENTATIVE. THE DEVICE WAS RECEIVED, AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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 WAS FOUND BROKEN IN THE TRAY UPON INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231162 REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM FORCEPS HTD WRIGHTS LANE SYNTHES USA PRODUCTS LLC 399.99 A7DA21 10886982203175

    Patients

    Seq Age Sex Outcome Treatment
    1