BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELF-RETAINING SCREWDRIVER FOR QUICK LOCK SCREWS

    MDR report key: 6641231 · Received June 14, 2017

    Report

    Report Number
    3003875359-2017-10289
    Event Type
    Malfunction
    Date Received
    June 14, 2017
    Report Date
    April 17, 2017
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HXX
    UDI-DI
    10705034713670
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTEDLY THERE WAS NO PATIENT INVOLVEMENT. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: JUNE 16, 2016. 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. A PRODUCT INVESTIGATION WAS COMPLETED: THE RETURNED SELF-RETAINING SCREWDRIVERS FOR CSLP QUICK LOCK SCREWS (PART 03.610.602, LOT 9896216) IS INCLUDED IN THE CSLP QUICK LOCK SCREWS TECHNIQUE GUIDE AND IS USED TO INSERT QUICK LOCK SCREWS. THE SCREWDRIVER HAD BENT PRONGS, BUT ONE OF ITS PRONGS WAS ALSO BROKEN OFF. AS PART OF THIS INVESTIGATION A VISUAL INSPECTION, DRAWING REVIEW, AND ROOT CAUSE ANALYSIS WERE PERFORMED. THE RELEVANT DRAWING WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION, AND DIMENSIONAL CONFORMITY WHEN USED AND HANDLED AS RECOMMENDED. DURING THE INVESTIGATION NO UNIDENTIFIED PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. BASED ON THE AVAILABLE INFORMATION IT IS NOT POSSIBLE TO DETERMINE A DEFINITIVE ROOT CAUSE FOR THE COMPLAINT CONDITIONS OF THE RETURNED PART. THE RETURNED SELF-RETAINING SCREWDRIVER FOR CSLP QUICK LOCK SCREWS IS USED TO INSERT QUICK LOCK SCREWS. IF A SCREW INSERTION WAS ATTEMPTED INTO EXCESSIVELY HARD BONE, IT IS POSSIBLE THAT THE RESULTING TORSIONAL FORCES COULD HAVE CONTRIBUTED TO DAMAGE SUSTAINED BY THE TIP OF THE RETURNED SELF-RETAINING SCREWDRIVER. DURING THE INVESTIGATION NO UNIDENTIFIED PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE 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

    IT WAS REPORTED THAT DURING THE INSPECTION OF FIELD EQUIPMENT ON (B)(6) 2017, A SELF-RETAINING SCREW DRIVERS FOR QUICK LOCK SCREWS WAS NOTED TO HAVE PRONGS ON THE TIP OF THE DEVICE THAT WERE BENT. IT WAS CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT. WHEN THE DEVICE WAS BEING EVALUATED BY THE MANUFACTURER, IT WAS ALSO NOTED THAT ONE OF THE PRONGS WAS BROKEN. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421233 SELF-RETAINING SCREWDRIVER FOR QUICK LOCK SCREWS SCREWDRIVERS HXX SYNTHES HAGENDORF 9896216 10705034713670

    Patients

    Seq Age Sex Outcome Treatment
    1