BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.5MM DRILL BIT/QC/GOLD/110MM

    MDR report key: 3269512 · Received August 7, 2013

    Report

    Report Number
    1719045-2013-01865
    Event Type
    Injury
    Date Received
    August 7, 2013
    Date of Event
    June 25, 2013
    Report Date
    July 15, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTW
    PMA / PMN Number
    K962913
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. LOT # U168484 REVEALED THE 2.5MM DRILL BIT WAS MANUFACTURED BY (B)(4). PO # 152114, FOR 232 PARTS, WAS INSPECTED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET NUMBER (B)(4) REVISION ¿A¿ ON (B)(4) 2013. THE PRODUCT CONFORMED TO ALL REQUIREMENTS. THE CERTIFICATE OF COMPLIANCE (C OF C) IS DATED (B)(4) 2013. 232 PARTS WERE RELEASED TO THE WAREHOUSE ON (B)(4) 2013. PO # 1528701, FOR 350 PARTS, WAS INSPECTED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET NUMBER (B)(4) REVISION ¿A¿ ON (B)(4) 2013. THE PRODUCT CONFORMED TO ALL REQUIREMENTS. THE CERTIFICATE OF COMPLIANCE (C OF C) IS DATED (B)(4) 2013. 238 PARTS WERE RELEASED TO THE WAREHOUSE ON (B)(4) 2013. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    COMPLAINT HANDLING UNIT RECEIVED A USER FACILITY REPORT FOR MEDWATCH NUMBERED (B)(4) ON (B)(4) 2013. AN UPDATED VERSION WAS SENT VIA FAX ON (B)(4) 2013. IT WAS REPORTED THAT THE SURGEON WAS DRILLING WITH A DRILL BIT TO PLACE A SCREW DURING A LEFT KNEE REVISION SURGERY, WHEN A PIECE OF THE DRILL BIT BROKE OFF IN THE PATIENT. THE PORTION OF THE DRILL BIT REMAINS IN THE BONE AS SITED ON THE POST PROCEDURE X-RAY; THERE IS NO APPARENT INJURY TO THE PATIENT AT THIS TIME. THE DRILL WAS NOTED AS BEING A STRYKER PRODUCT AND ONLY THE DRILL BIT IS A DEPUY SYNTHES PRODUCT. STRYKER HAS PROVIDED THE INSPECTION RECORDS FOR THEIR DEVICE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370221 2.5MM DRILL BIT/QC/GOLD/110MM HTW SYNTHES MONUMENT U168484

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention