BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM CANNULATED DRILL BIT/QC 150MM

    MDR report key: 3823873 · Received May 21, 2014

    Report

    Report Number
    3000270450-2014-10026
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 30, 2014
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HWE
    PMA / PMN Number
    PK962913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNKNOWN DATE AND MONTH IN 1945. ADDITIONAL PRODUCT CODES: HSZ, GFA, GFF. 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. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING HEADLESS COMPRESSION SCREW SURGERY ON PROXIMAL ULNA, TWO GUIDE DRILL BITS WERE BROKEN AND SMALL TIPS OF DRILL BITS WERE LEFT IN THE BONE. THERE WAS A SURGICAL DELAY OF FIVE TO TEN MINUTES, BUT THE SURGERY FINISHED WITHOUT REMOVAL. THERE IS NO PLAN TO OPERATE ADDITIONAL SURGERY FOR THIS MATTER. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302803 2.0MM CANNULATED DRILL BIT/QC 150MM INSTR, SURGICAL, ORTHOPEDIC, AC- POWERED MOTOR/ACCESS & ATTACH HWE SYNTHES SELZACH F-15693

    Patients

    Seq Age Sex Outcome Treatment
    1