BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE SCREWDRIVER SHAFT T8 105MM

    MDR report key: 7003023 · Received November 6, 2017

    Report

    Report Number
    1719045-2017-11140
    Event Type
    Malfunction
    Date Received
    November 6, 2017
    Date of Event
    October 4, 2017
    Report Date
    October 11, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    KWQ
    UDI-DI
    10886982188922
    PMA / PMN Number
    K152239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS PERFORMED. THE RETURNED INSTRUMENT WAS EXAMINED AND THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED AS THE DEVICE WAS FOUND TO HAVE A BROKEN AND TWISTED DISTAL TIP. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED HOWEVER THE FAILURE MODE IS TYPICALLY ASSOCIATED WITH THE APPLICATION OF EXCESSIVE FORCE DURING SCREW INSERTION/REMOVAL; BASED ON THE DIRECTION OF THE TWISTED TIP, THE FAILURE OCCURRED DURING INSERTION. THE COMPLAINT CONDITION WAS UNABLE TO BE REPLICATED DUE TO POST-MANUFACTURING DAMAGE. A VISUAL INSPECTION AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THIS COMPLAINT IS CONFIRMED. THE T8 STARDRIVE SCREWDRIVER SHAFT (314.467) IS A COMMON TRAUMA INSTRUMENT, NOTED IN 30 SYSTEM TECHNIQUE GUIDES INCLUDING: 2.4MM VA LCP DISTAL RADIUS, COMPACT DISTAL RADIUS AND MODULAR CLAVICLE PLATE. IN EACH INSTANCE THE INSTRUMENT IS UTILIZED FOR SCREW INSERTION/REMOVAL. 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. THE LENGTH OF THE SCREWDRIVER WAS MEASURED AND IS WITHIN THE SPECIFICATION FOR OVERALL LENGTH, AS SUCH THE TIP FRAGMENT IS UP TO 1.97MM LONG. FURTHER DIMENSIONAL INSPECTION COULD NOT BE PERFORMED FOR THE DISTAL TIP AS IT WAS NOT RECEIVED. DURING THE INVESTIGATION NO 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.

    Additional Manufacturer Narrative · 1

    PATIENT¿S AGE/ DATE OF BIRTH AND WEIGHT ARE UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART # 314.467, LOT # H231209, SUPPLIER LOT NUMBER: N/A: RELEASE TO WAREHOUSE DATE: 28-DEC-2016, EXPIRATION DATE: N/A, MANUFACTURED BY SYNTHES (B)(4): NO NON-CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE HAS BEEN RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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 THE TIP OF THE SCREWDRIVER BROKE OFF WHEN INSERTING A SCREW DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) LEFT WRIST ON (B)(6) 2017. THE SCREWDRIVER TIP WAS RECOVERED; NOTHING WAS LEFT IN THE PATIENT. ANOTHER SCREWDRIVER WAS USED TO COMPLETE THE SURGERY WITH NO DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH SUCCESSFUL PATIENT OUTCOME. NO PATIENT HARM WAS REPORTED. CONCOMITANT DEVICE REPORTED: SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER SHAFT T8 105MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782252 STARDRIVE SCREWDRIVER SHAFT T8 105MM APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY KWQ SYNTHES MONUMENT H231209 10886982188922

    Patients

    Seq Age Sex Outcome Treatment
    1