BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    MDR report key: 12681155 · Received October 22, 2021

    Report

    Report Number
    2939274-2021-06246
    Event Type
    Malfunction
    Date Received
    October 22, 2021
    Report Date
    August 27, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTJ
    UDI-DI
    10886982189943
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTER IS A SYNTHES EMPLOYEE. PART # 319.006, SYNTHES LOT # H873103, SUPPLIER LOT # H873103, RELEASE TO WAREHOUSE DATE: APRIL 27, 2020, SUPPLIER: AVALIGN TECHNOLOGIES-NEMCOMED. NO NCRS WERE GENERATED DURING PRODUCTION. 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. VISUAL INSPECTION: THE DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS (P/N:319.006, LOT #: H873103) WAS RETURNED AND RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE DEVICE WAS MISSING THE PROTECTION SLEEVE, WHICH CONFIRMS THE COMPLAINT CONDITION. THE NEEDLE COMPONENT WAS OBSERVED TO BE SLIGHTLY BENT. NO OTHER ISSUES WERE IDENTIFIED. DIMENSIONAL INSPECTION: A DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO THE DEFINITIVE FINDING OF A MISSING COMPONENT. DOCUMENT/SPECIFICATION REVIEW: THE FOLLOWING DRAWINGS WERE REVIEWED DURING THE INVESTIGATION: CURRENT AND MANUFACTURED REVISIONS DEPTH GAUGE FOR 2.0MM TO 2.4MM SCREWS NO DESIGN ISSUES OR DISCREPANCIES WERE NOTICED. COMPLAINT CONFIRMED? YES. INVESTIGATION CONCLUSION: THE COMPLAINT CONDITION WAS CONFIRMED FOR THE RECEIVED DEVICE DUE TO THE DEFINITIVE FINDING OF A MISSING COMPONENTS. HOWEVER, THE COMPONENTS ARE ABLE TO BE DISASSEMBLED AND WERE LIKELY MISPLACED DURING THE DEVICE'S HANDLING. 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 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, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET AT THE FIELD SERVICE LOCATION, IT WAS OBSERVED THAT THE DEPTH GAUGE WAS MISSING A COMPONENT. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT INVOLVES ONE (1) DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1581279 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS GAUGE, DEPTH HTJ WRIGHTS LANE SYNTHES USA PRODUCTS LLC 319.006 H873103 10886982189943

    Patients

    Seq Age Sex Outcome Treatment
    1