BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS

    MDR report key: 3951213 · Received July 22, 2014

    Report

    Report Number
    2530088-2014-10190
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Report Date
    June 25, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HTJ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SERVICE HISTORY REVIEW CANNOT BE PERFORMED FOR LOT# 3962293 AS THIS IS A LOT CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS JULY 22, 1999. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. 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 AND DOCUMENTED THAT THE TIP IS BROKEN AND THE WIRE IS BENT ON THE DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS. COMPLAINT ISSUE DISCOVERED DURING STERILE PROCESSING. IT WAS CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT DUE TO ISSUE BEING FOUND OUTSIDE OF OPERATING ROOM. THIS IS NOT FOR A WARRANTY REPLACEMENT ONLY. THIS EVENT DID NOT CONTRIBUTE TO A DEATH OR INJURY. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427847 DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS GAUGE,DEPTH HTJ SYNTHES BRANDYWINE 3962293

    Patients

    Seq Age Sex Outcome Treatment
    1