BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    MDR report key: 3163950 · Received June 12, 2013

    Report

    Report Number
    2530088-2013-00911
    Event Type
    Malfunction
    Date Received
    June 12, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HTJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE DEVICE HISTORY RECORD WAS REVIEWED AND MRR #(B)(4) WAS FOUND ON RAW MATERIAL (B)(4) FOR ØA OVERSIZE. THE MATERIALS MANAGER REVIEWED THE ISSUE AND ACCEPTED THE NONCONFORMING MATERIAL USE AS IS. THIS NONCONFORMANCE IS NOT RELEVANT TO THIS COMPLAINT CONDITION BECAUSE IT IS FOR THE PLASTIC RAW MATERIAL USED FOR THE HANDLE NOT THE ALUMINUM PARTS THAT SLIDE. NO ISSUES WERE FOUND DURING MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INSTRUMENT IS CHECKED VISUALLY AND FUNCTIONALLY 100% AT MANUFACTURE AND PASSED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS RETURNED FOR EVALUATION. (B)(4). THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Description of Event or Problem · 1

    REPORTEDLY THREE (3) DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS WERE AVAILABLE FOR A SURGERY ON (B)(6) 2013; HOWEVER THE INSTRUMENTS DID NOT FUNCTION AS INTENDED. IT WAS REPORTED THE FIRST DEPTH GAUGE (LOT # 4239292) WAS TOO LOOSE. THE SECOND DEPTH GAUGE (LOT #3958363) WOULD NOT SLIDE SMOOTHLY. IN ADDITION THE THIRD DEPTH GAUGE (LOT #4070014) WAS FOUND TO HAVE A BROKEN TIP. THE SURGEON WAS ABLE TO USE THE LOOSE DEPTH GAUGE TO COMPLETE THE PROCEDURE. APPROXIMATELY SIX MINUTES WAS ADDED TO THE PROCEDURE DUE TO THIS EVENT. THERE WAS NO PATIENT HARM REPORTED. THIS IS 1 OF 3 REPORTS FOR THE SAME EVENT, COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266835 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS HTJ SYNTHES BRANDYWINE 3958363

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR