BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM CANCELLOUS BONE SCREW PARTIALLY THREADED/45MM

    MDR report key: 5278601 · Received December 9, 2015

    Report

    Report Number
    2520274-2015-17747
    Event Type
    Malfunction
    Date Received
    December 9, 2015
    Date of Event
    November 18, 2015
    Report Date
    November 18, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    PPREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODE: HWC. (B)(4). DEVICE IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. ADDITIONAL 510K # K083213, HRS: PLATE, FIXATION, BONE. SUBJECT DEVICE HAS NOT BEEN RECEIVED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    (B)(6) REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION OF A PATELLA ON (B)(6) 2015 A 4MM CANCELLOUS SCREW BROKE DURING INSERTION AFTER DRILLED WITH A 2.5MM DRILL BIT. A SCREW REMOVAL SET WAS USED TO REMOVE THE SCREW FRAGMENTS. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT READILY AVAILABLE DEVICE AND A 5 TO 10 MINUTE SURGICAL DELAY. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810316 4.0MM CANCELLOUS BONE SCREW PARTIALLY THREADED/45MM SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1