BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE SCREWDRIVER T8

    MDR report key: 6305369 · Received February 6, 2017

    Report

    Report Number
    1719045-2017-10084
    Event Type
    Malfunction
    Date Received
    February 6, 2017
    Date of Event
    January 31, 2017
    Report Date
    January 31, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    UDI-DI
    10886982071859
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS COMPLETED: THE SCREWDRIVER WAS RETURNED WITH THE END CAP INSTALLED. THERE IS A CRACK IN THE HANDLE THROUGH THE SECTION WHICH HOLDS THE END CAP. THERE ARE NO BROKEN FRAGMENTS FROM THE HANDLE. THE END CAP DOES NOT FALL OUT ON ITS OWN. THE DEVICE IS OTHERWISE IN GOOD CONDITION. A VISUAL INSPECTION, DRAWING REVIEW AND DEVICE HISTORY RECORD REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE COMPLAINT REGARDING THE CRACKED HANDLE IS CONFIRMED. REPLICATION OF THE COMPLAINT CONDITION IS NOT APPLICABLE AS THE DEVICE IS ALREADY CRACKED. THE SCREWDRIVER IS NOTED IN MULTIPLE TRAUMA SYSTEM TECHNIQUE GUIDES INCLUDING: 2.4MM LCP DISTAL RADIUS AND PEDIATRIC LCP PLATE. IN EACH INSTANCE THE DRIVER IS AVAILABLE FOR THE INSERTION OF 2.7MM SCREWS. THE RELEVANT DRAWINGS WERE REVIEWED DURING INVESTIGATION. THE DESIGN HISTORY WAS NOT FOUND TO IMPACT THE COMPLAINT CONDITION. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED. THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD 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 USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED TO SYNTHES MANUFACTURER FOR EVALUATION /INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: DHR REVIEW FOR: DHR REVIEW FOR PART: #03.110.007 -SYNTHES LOT # 7893405. RELEASE TO WAREHOUSE DATE: (B)(6) 2015. EXPIRATION DATE: NA. MADE BY: (B)(6). NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURING 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PROXIMAL SWIVEL METAL PART OF THE SCREWDRIVER CAME APART FROM THE SCREWDRIVER HANDLE DURING PLATE REMOVAL ON (B)(6) 2017. THE REASON OF DISMANTLING IS THAT THE SCREWDRIVER HANDLE IS CRACKED AND NOT REPAIRABLE. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. NO MORE INFORMATION IS AVAILABLE AT THIS TIME. THIS COMPLAINT INVOLVES ONE DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88301 STARDRIVE SCREWDRIVER T8 SCREWDRIVERS HXX SYNTHES MONUMENT 7893405 10886982071859

    Patients

    Seq Age Sex Outcome Treatment
    1