BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED STARDRIVE SCRWDRVR SHAFT FOR 3.0MM HCD T8

    MDR report key: 4204599 · Received October 27, 2014

    Report

    Report Number
    3003875359-2014-10343
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 29, 2014
    Report Date
    September 29, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A PRODUCT EVALUATION WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES INDICATES THAT: THE RETURNED SCREWDRIVER SHAFT WAS RECEIVED AS COMPLAINED WITH THE TIP BROKEN. THE BROKEN TIP WAS NOT RECEIVED. THE BALANCE OF THE TOOL IS IN GOOD CONDITION AND THE ETCHINGS ARE LEGIBLE. THE MANUFACTURE DATE IS MAY 03, 2006. THE FAILURE OF THIS INSTRUMENT IS LIKELY THE RESULT OF TORQUE IN EXCESS OF THAT REQUIRED FOR ITS INTENDED USE RATHER THAN A DESIGN DEFICIENCY. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. THE COMPLAINT IS CONFIRMED. 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY RECORDS WAS CONDUCTED. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE 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

    DATE RETURNED TO MANUFACTURER SHOULD BE 10/08/2014. 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, WHILE INSERTING A 2.4MM HEADLESS COMPRESSION SCREW, THE TIP OF THE CANNULATED STARDRIVE SCREWDRIVER SHAFT BROKE OFF. THE SURGEON REMOVED THE SCREW AND SUCCESSFULLY COMPLETED THE PROCEDURE WITH ANOTHER SCREW AND SCREWDRIVER SHAFT. IT WAS REPORTED THAT ALL FRAGMENTS WERE RETRIEVED AND NONE REMAINED IN THE PATIENT. NO ISSUES WERE REPORTED WITH THE SCREW. THERE WAS A 15 TO 20 MINUTE DELAY IN SURGERY REPORTED. NO PATIENT HARM WAS REPORTED. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683412 CANNULATED STARDRIVE SCRWDRVR SHAFT FOR 3.0MM HCD T8 SCREWDRIVERS HXX SYNTHES HAGENDORF 2179561

    Patients

    Seq Age Sex Outcome Treatment
    1