BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.0 MM AND 2.4 MM SCREWS

    MDR report key: 3964518 · Received July 29, 2014

    Report

    Report Number
    3003787298-2014-10036
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Report Date
    July 1, 2014
    Manufacturer
    SYNTHES JENNERSVILLE
    Product Code
    HTJ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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 SERVICE AND REPAIR RECORDS HAS BEEN REQUESTED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    SERVICE HISTORY REVIEW: NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. SERVICE HISTORY EVALUATION IS UNCONFIRMED.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 THE DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS HAS A BROKEN TIP, THE ISSUE WAS FOUND DURING STERILE PROCESSING. NO PATIENT INVOLVEMENT DUE TO COMPLAINT ISSUE BEING DISCOVERED OUTSIDE OF THE OPERATING ROOM THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440896 DEPTH GAUGE FOR 2.0 MM AND 2.4 MM SCREWS GAUGE, DEPTH HTJ SYNTHES JENNERSVILLE 7024504

    Patients

    Seq Age Sex Outcome Treatment
    1