BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE FOR HOOK OR SCREW HOLDER

    MDR report key: 9641670 · Received January 29, 2020

    Report

    Report Number
    2939274-2020-00505
    Event Type
    Malfunction
    Date Received
    January 29, 2020
    Report Date
    January 8, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    UDI-DI
    10705034773643
    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: DAMAGE. VISUAL INSPECTION: THE HANDLE FOR HOOK OR SCREW HOLDER (P/N: 388.621, LOT NUMBER: 5031269) WAS RECEIVED AT US CQ. VISUAL INSPECTION OF THE COMPLAINT DEVICE SHOWED SEVERAL CHUNKS HAVE BROKEN OFF AND THE OTHER SIDE OF THE HANDLE WAS CRACKED. DEVICE FAILURE/DEFECT IDENTIFIED? YES. DIMENSIONAL INSPECTION: NO DIMENSIONAL INSPECTION CAN BE PERFORMED DUE TO POST MANUFACTURING DAMAGE. DOCUMENT/SPECIFICATION REVIEW: NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. COMPLAINT CONFIRMED? YES. INVESTIGATION CONCLUSION: THIS COMPLAINT IS CONFIRMED AS THE HANDLE IS CRACKED AND BROKEN. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. 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 NUMBER: 388.621, SYNTHES LOT NUMBER: 5031269, SUPPLIER LOT NUMBER: N/A, RELEASE TO WAREHOUSE DATE: JUN 21, 2005, EXPIRATION DATE: N/A, SUPPLIER: (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORD 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 THAT ON (B)(6) 2019, ONE (1) LOCKING BOLT MEASURING DEVICE FOR TROCHANTERIC FIXATION NAILS WAS FOUND TO BE BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104253 HANDLE FOR HOOK OR SCREW HOLDER MISC ORTHO SURGICAL INSTR LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 388.621 5031269 10705034773643

    Patients

    Seq Age Sex Outcome Treatment
    1