BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACT-BOLT F/SCR Ø2

    MDR report key: 3171657 · Received June 15, 2013

    Report

    Report Number
    8030965-2013-02875
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Report Date
    June 4, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(6). MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE CONDUCTED INVESTIGATION SHOWED THAT BOTH INSTRUMENTS WERE MANUFACTURED IN ACCORDANCE WITH THE SPECIFICATIONS. BOTH PARTS BROKE IN THE FRONT AREA. THE INSTRUMENTS ARE OF A DELICATE DESIGN, BUT THERE IS EVIDENCE THAT EXCESSIVE MECHANICAL FORCES DURING SCREW REMOVAL LED TO THE CRACKS. WE FURTHER INVESTIGATION REGARDING THE MANUFACTURING PROCESS AND THE MATERIALS DID NOW SHOW ANY DEVIATION FROM THE SPECIFICATIONS. THE CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE ON AN UNKNOWN DATE, THE TIPS OF TWO BOLT EXTRACTOR DEVICES BROKE OFF. IT WAS REPORTED THAT THEY BROKE DURING PREPARATION, WITH NOT MUCH APPLIED MECHANICAL FORCE. ALL FRAGMENTS WERE RETRIEVED WITH A VACUUM HOSE, AND NONE REMAIN IN THE PATIENT. THE SURGEON CARRIED OUT AN INTEROPERATIVE X-RAY TO MAKE SURE OF THIS. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272635 EXTRACT-BOLT F/SCR Ø2 HWB SYNTHES GMBH 2675321

    Patients

    Seq Age Sex Outcome Treatment
    1