BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE SCREWDRIVER SHAFT T8105MM

    MDR report key: 6129105 · Received November 28, 2016

    Report

    Report Number
    1719045-2016-10854
    Event Type
    Malfunction
    Date Received
    November 28, 2016
    Date of Event
    November 3, 2016
    Report Date
    November 3, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    KWQ
    PMA / PMN Number
    K152239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. MANUFACTURER: SYNTHES (B)(4). DATE OF MANUFACTURE (RELEASE TO WAREHOUSE DATE): OCT 27, 2005. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. 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 USED FOR TREATMENT, NOT DIAGNOSIS A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE T8 STARDRIVE SCREWDRIVER SHAFT (PART NUMBER 314.467, LOT NUMBER 5021328). THE SUBJECT DEVICE WAS RETURNED WITH THE COMPLAINT CONDITION STATING THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED AS THE DISTAL TIP OF THE DRIVER WAS BROKEN AND MISSING A SEGMENT OF APPROXIMATELY 2MM LONG X 3MM IN DIAMETER ¿MEASURED WITH CALIPERS. 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. 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 NO NON-CONFORMANCE RECORDS 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 FAILURE MODE IS TYPICALLY ASSOCIATED WITH THE APPLICATION OF EXCESSIVE FORCE. 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 A STARDRIVE SCREWDRIVER SHAFT BROKE WHILE EXPLANTING AN UNKNOWN SCREW ON (B)(6) 2016. IT IS UNKNOWN WHY PATIENT WAS HAVING IMPLANTS REMOVED AND IF HE/SHE WAS REVISED WITH NEW PRODUCT. IT IS ALSO UNKNOWN IF THE EXPLANTED PRODUCT WAS SYNTHES. PATIENT¿S TYPE OF ORIGINAL SURGERY, POSTSURGICAL OUTCOME AND SURGICAL DELAY (IF ANY) ARE UNKNOWN. CONCOMITANT DEVICE REPORTED: SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780058 STARDRIVE SCREWDRIVER SHAFT T8105MM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ SYNTHES MONUMENT 5021328

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN SCREW, QTY 1