BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE SCREWDRIVER SHAFT T8 105MM

    MDR report key: 4211041 · Received October 29, 2014

    Report

    Report Number
    1719045-2014-10549
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 2, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    OVE
    PMA / PMN Number
    PK112459
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A MANUFACTURING INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (STARDRIVE SCREWDRIVER SHAFT, PART NUMBER 314.467). THE TIP OF THE SUBJECT DEVICE WAS RECEIVED IN A TWISTED, BUT NOT APPARENTLY BROKEN CONDITION. THE PART WAS MANUFACTURED TO THE REQUIRED SPECIFICATIONS AND MET ALL REQUIREMENTS AT THE TIME OF MANUFACTURING. THE PART EVALUATION CONFIRMED THAT AFFECTED DIMENSIONS ARE WITHIN SPECIFICATION. BASED ON THE UNKNOWN ROOT CAUSE, THE COMPLAINT CONDITION IS CONFIRMED, THOUGH NOT LIKELY DUE TO A MANUFACTURING CAUSE. 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.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 IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. REVIEW OF THE DEVICE HISTORY RECORDS FOR PART NUMBER 314.467, LOT 7575343, SHOWED NO NON-CONFORMANCES GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE 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

    (B)(4). 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 TIP OF SCREWDRIVER BROKE OF WITHIN THE RECESS OF A 2.7 VARIABLE ANGLE LOCKING SCREW DURING USE WITH THE TORQUE LIMITER. THERE WAS NO DELAY IN THE PROCEDURE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691665 STARDRIVE SCREWDRIVER SHAFT T8 105MM INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, CERVICAL OVE SYNTHES MONUMENT 7575343

    Patients

    Seq Age Sex Outcome Treatment
    1