BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS

    MDR report key: 9647720 · Received January 30, 2020

    Report

    Report Number
    2939274-2020-00543
    Event Type
    Malfunction
    Date Received
    January 30, 2020
    Report Date
    January 8, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTJ
    UDI-DI
    10886982196255
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: INVESTIGATION FLOW: VISUAL. VISUAL INSPECTION: THE LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS (P/N: 357.402, LOT #: 4940004) WAS RECEIVED AT US CQ. UPON VISUAL INSPECTION, THE DEVICE IS MISSING THE BALL AND SPRING COMPONENTS. DOCUMENT/SPECIFICATION REVIEW: NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTIONS RELEVANT TO THIS COMPLAINT WERE NOT PERFORMED AT DUE TO A DEFINITIVE FINDING OF A MISSING COMPONENT. CONCLUSION: THE OVERALL COMPLAINT WAS NOT CONFIRMED FOR THE RECEIVED LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS (P/N: 357.402, LOT #: 4940004) AS THE DEVICE IS MISSING THE BALL AND SPRING COMPONENTS BUT IS NOT BROKEN. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. 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: PART # 357.402. SYNTHES LOT # 4940004. SUPPLIER LOT # NA. RELEASE TO WAREHOUSE DATE: FEB 11, 2005. MANUFACTURED BY SYNTHES BRANDYWINE. NO NCR'S WERE GENERATED DURING PRODUCTION. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 (B)(6) 2020, ONE (1) STEPPED DRILL BIT CANNULATED DID NOT FUNCTION; SIX (6) DEPTH GAUGE FOR LOCKING SCREWS, TWO (2) LOCKING BOLT MEASURING DEVICE, AND ONE (1) TITANIUM STERNAL LOCKING STRAIGHT PLATE WERE FOUND TO BE BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR (1) LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS. THIS IS REPORT 04 OF 10 OF (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111964 LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS GAUGE,DEPTH HTJ WRIGHTS LANE SYNTHES USA PRODUCTS LLC 357.402 4940004 10886982196255

    Patients

    Seq Age Sex Outcome Treatment
    1