BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T25 STARDRIVE SHAFT F/MATRIX STANDARD

    MDR report key: 4250559 · Received November 14, 2014

    Report

    Report Number
    2520274-2014-14738
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 22, 2014
    Report Date
    October 22, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED 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. 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

    A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT IT SHOWED NO NONCONFORMANCES GENERATED DURING PRODUCTION. REVIEW OF THE RAW MATERIAL DHR FOR P/N 11156, LOT 5186613, SHOWED A REWORK ASSOCIATED WITH CAPA (B)(4). THE REWORK ADDED A MARK TO THE BAR STOCK TO INDICATE ALLOY TYPE AND LOT NUMBER TO ENSURE USE OF CORRECT ALLOY FOR PRODUCT. THE BARS PASSED INSPECTION USING XRFA ANALYSIS TO CONFIRM ALLOY TYPE. THIS REWORK IS NOT RELEVANT TO THE COMPLAINT CONDITION AS THE BAR MARK IS ON THE END OF THE BAR STOCK. REVIEW OF THE DHRS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    MANUFACTURING INVESTIGATION: SCREWDRIVER SHAFT T25 STARDRIVE - LOT 6633364 DUE TO AN UNKNOWN CAUSE, THE DEVICE WAS USED IN SURGERY IN WHICH THE HOLDING SLEEVE THREADS BROKE; NO COMPLAINT WAS NOTED FOR THIS PART, BUT DAMAGE SUSPECTED. UPON RECEIPT OF THE PART, THERE WAS NO EVIDENCE OF DAMAGE. THE MATERIAL AND DIMENSIONS OF THIS PART ARE PER SPECIFICATION. BASED ON THE EVALUATION AND THE UNKNOWN CAUSE, THIS COMPLAINT IS CONSIDERED UNCONFIRMED AND IS NOT MANUFACTURING-RELATED. DEVICE 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 THERE IS A POSSIBILITY OF DEFORMITY DAMAGE OF THE STAR DRIVE AND THE THREADS INSIDE THE BONE SCREW HEAD OF 04.632.750. THE DAMAGE TO THE THREADS ON THE TIP OF THE HOLDING SLEEVE OF 03.632.002 WAS FOUND. THE MATRIX SYSTEM WAS USED FOR AN INTERVERTEBRAL STENOSIS AT L4-L5 REGION. DURING THE SURGERY, THE SURGEON DECIDED TO REPLACE A SCREW FOR L5 AFTER HE INSERTED FOUR PEDICLE SCREWS AT L4-L5. HE DISTRACTED THE SCREW AT L5 USED BY A T25 STARDRIVE STRAIGHT HAND, AND THEN HE ATTEMPTED TO IMPLANT AGAIN A COMPONENT OF THE STAR DRIVE SHAFT, 03.632.002 AND THE HOLDING SLEEVE, 03.632.001. HOWEVER, THE DRIVER COULD NOT PICK THE SCREW AND HE FOUND THE DIFFICULTY OF ITS IMPLANT. HE ALSO FOUND THAT THERE WAS A BREAKAGE OF THE THREAD OF THE HOLDING SLEEVE. ALTHOUGH HE TRIED TO COMPOSE ANOTHER SLEEVE AND ANOTHER STAR DRIVE SHAFT, THE DAMAGE OCCURRED ON THE SLEEVE AGAIN AS HE EXPERIENCED IT BEFORE PRIOR. THE SURGEON USED A NEW SCREW AND NEW IMPLANTS TO COMPLETE THE SURGERY. THE SURGERY WAS EXTENDED FOR 30 MIN DUE TO THIS EVENT. THIS REPORT IS 4 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735983 T25 STARDRIVE SHAFT F/MATRIX STANDARD SCREWDRIVERS HXX SYNTHES MONUMENT 6633364

    Patients

    Seq Age Sex Outcome Treatment
    1