BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAR/HEXDRIVE SCREWDRIVER T25 3.5MM HEX/SELF-RETAINING

    MDR report key: 5955602 · Received September 16, 2016

    Report

    Report Number
    2530088-2016-10244
    Event Type
    Malfunction
    Date Received
    September 16, 2016
    Report Date
    September 1, 2016
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. PART NUMBER: 03.010.150, SYNTHES LOT NUMBER: 5071417: RELEASE TO WAREHOUSE DATE: SEPTEMBER 9, 2005. MFG SITE: (B)(4). 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 THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    A PRODUCT INVESTIGATION WAS COMPLETED: DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. A VISUAL INSPECTION, COMPLAINT HISTORY REVIEW, DRAWING REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THIS COMPLAINT IS CONFIRMED. THE RETURNED INSTRUMENT WAS EXAMINED AND THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED AS A DISTAL PORTION OF THE HANDLE WAS FOUND TO BE MISSING. RELEVANT DRAWINGS FOR THE RETURNED INSTRUMENT WERE REVIEWED. THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THESE DEVICES. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE RETURNED INSTRUMENT¿S LOT NUMBER AND IN EACH INSTANCE NO MATERIAL REVIEW REPORTS, NON-CONFORMANCE REPORTS OR COMPLAINT-RELATED ISSUES WERE IDENTIFIED WITH THE LOT NUMBER WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED HOWEVER THE DEVICE HANDLES ARE COMPOSED OF PHENOLIC LE GRADE WHICH IS SUSCEPTIBLE TO BECOMING BRITTLE AFTER REPEATED THERMAL CYCLE SUCH AS THAT WHICH WOULD OCCUR DURING THE STERILIZATION CYCLE. THE DEVICE IS 11+ YEARS OLD, AS SUCH INSTRUMENT AGE LIKELY CONTRIBUTED TO THE COMPLAINT CONDITION. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITIONS. 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 ON (B)(6) 2016 THAT DURING A ROUTINE INSPECTION OF FIELD EQUIPMENT IT WAS FOUND THAT THE STAR/HEXDRIVE SCREWDRIVER T25 HAS A CHIP IN THE HANDLE. NO PATIENT INVOLVEMENT. THIS IS REPORT NUMBER 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608787 STAR/HEXDRIVE SCREWDRIVER T25 3.5MM HEX/SELF-RETAINING SCREWDRIVERS HXX SYNTHES BRANDYWINE 5071417

    Patients

    Seq Age Sex Outcome Treatment
    1