BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 4102804 · Received September 19, 2014

    Report

    Report Number
    2520274-2014-13753
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Report Date
    August 25, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A PD EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT THE ONE EXTRACTION BOLT FOR 2.7 MM (PART# 309.290, LOT# 2221353, MFG NOV2006) WAS RETURNED. THIS DEVICE IS FOR THE REMOVAL OF THE FOLLOWING SCREWS: 2.4 MM (CRUCIFORM AND T8 STARDRIVE), 2.7 MM (2.5MM HEX, T8 STARDRIVE, T15 STARDRIVE), AND IS INCLUDED IN THE SCREW REMOVAL SET, THE TECHNIQUE GUIDE (J8569-C) WAS REVIEWED FOR THE PROPER USE OF THIS DEVICE. THIS PART WAS RETURNED WITH THE COMPLAINT THAT ¿AN EXTRACTION BOLT FOR 2.7MM SCREWS HAD AN UNKNOWN SCREW BREAK OFF INSIDE IT.¿ THIS COMPLAINT IS CONFIRMED AS THE EXTRACTION BOLT WAS RETURNED WITH A SEGMENT OF FRACTURED SCREW SLIGHTLY PROTRUDING FROM THE DISTAL CANNULATED END, IT IS NOT AN EVEN BREAK, AND ONLY A PORTION OF THE TOTAL DIAMETER IS VISIBLE SO THE SIZE OF THE SCREW WHICH BROKE OFF IN THE DEVICE CANNOT BE MEASURED. IT IS NOT KNOWN WHAT CIRCUMSTANCES LED TO THE SCREW BREAKING OFF INTO THE EXTRACTION BOLT, WHAT SIZE SCREW WAS BEING REMOVED, OR IF THIS OCCURRED DURING SCREW REMOVAL OR AFTER THE ENTIRE SCREW HAD BEEN REMOVED. THE ROOT CAUSE OF THIS COMPLAINT IS UNDETERMINED. THIS COMPLAINT IS CONFIRMED, HOWEVER THE ROOT CAUSE COULD NOT BE DETERMINED. THIS DEVICE IS ADEQUATE FOR ITS INTENDED USE AND DID NOT 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. 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 THAT AN EXTRACTION BOLT FOR 2.7MM SCREWS HAD AN UNKNOWN SCREW BREAK OFF INSIDE IT. IT IS UNKNOWN WHEN THIS OCCURRED AND WHETHER OR NOT A PATIENT WAS INVOLVED. THIS REPORT IS FOR AN UNKNOWN SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583989 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1