BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE SCREWDRIVER SHAFT T8 55MM

    MDR report key: 6058152 · Received October 26, 2016

    Report

    Report Number
    2520274-2016-15083
    Event Type
    Malfunction
    Date Received
    October 26, 2016
    Date of Event
    April 28, 2016
    Report Date
    October 7, 2016
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (STARDRIVE SCREWDRIVER SHAFT T8 55MM), PART NUMBER 314.453, LOT NUMBER 9874393. THE SUBJECT DEVICE WAS RETURNED WITH THE COMPLAINT CONDITION STATING THAT THE SCREWDRIVER SHAFT 2.4 RECEIVED IN A USED CONDITION. VISUAL INSPECTION SHOWED SLIGHT WEAR MARKS ON THE TIP SECTION AND THE FIRST 1MM HAS DISCOLORED. THE MEASURED DIMENSIONS DID PASS THE TOLERANCES OF THE MANUFACTURING DRAWING. DEVICE HISTORY RECORD REVIEW CONCLUDED THAT NO NON-CONFORMANCES WERE GENERATED DURING PRODUCTION AND WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A FUNCTIONAL TEST WAS PROVIDED WITH A LOCKING SCREW STARDRIVE AND IT WAS POSSIBLE TO MOUNT THE SCREW FULLY ON TO THE SCREWDRIVER. THE COMPLAINED ISSUE OF (THE SCREWDRIVER DID NOT FIT WITH THE SCREW) COULD NOT BE REPLICATED AND NOT CONFIRMED. THE TIP SECTION IS IN A USED CONDITION BUT STILL FUNCTIONAL. NO MANUFACTURING RELATED DEVIATION COULD BE FOUND. 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

    (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: DHR REVIEW FOR PART: # 314.453 / LOT # 9874393 MANUFACTURING LOCATION: (B)(4); MANUFACTURING DATE: 5TH APRIL 2016; LOT OF 48 PIECES WAS RELEASED BASED ON STEP 0080 OF WORK ORDER (B)(4). NEITHER DEVIATION NOR ANY NCRS WERE MARKED IN THIS DOCUMENT. SYNTHES MANUFACTURING LOCATION WAS DISCOVERED UPON RECEIPT OF SUBJECT DEVICE. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE SCREWDRIVER SHAFT WAS USED IN SURGERY ON THE FRACTURE OF THE DISTAL RADIUS ON (B)(6) 2016. THE SCREWDRIVER DID NOT FIT WITH THE SCREW. A SUBSTITUTED SCREWDRIVER SHAFT WAS USED. THERE WAS NO SURGICAL EXTENSION. REPORTED CONCOMITANT DEVICES: SCREW (PART/LOT UNKNOWN, QUANTITY: 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708696 STARDRIVE SCREWDRIVER SHAFT T8 55MM SCREWDRIVERS HXX SYNTHES HAGENDORF 9874393

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN SCREW