BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-HANDLE T25 STARDRIVE SHAFT F/MATRIX-LONG

    MDR report key: 4251542 · Received November 14, 2014

    Report

    Report Number
    1719045-2014-10591
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 8, 2014
    Report Date
    November 11, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. REVIEW OF THE DEVICE HISTORY RECORDS FOR PART NUMBER 03.632.074, LOT 6670699, SHOWED NO NONCONFORMANCES GENERATED DURING PRODUCTION. REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORDS FOR PART NUMBER 11156, LOT 5265813, SHOWED NO NONCONFORMANCES 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. A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: THE T-HANDLE DRIVER WAS RETURNED WITH THE LOBES AT THE STARDRIVE TIP CHIPPED. THE REST OF THE INSTRUMENT HAD WEAR CONSISTENT WITH NORMAL USE. ONE T-HANDLE T25 STARDRIVE SHAFT (PART 03.632.074 LOT 6670699) WAS RETURNED FOR REPORTEDLY BEING DAMAGED AFTER FALLING ON THE FLOOR. THE DRIVER IS INCLUDED IN THE MATRIX DEFORMITY AND DEGENERATIVE SPINE SYSTEMS AND USED FOR PEDICLE SCREW AND LOCKING CAP INSERTION AND PROVISIONAL TIGHTENING. THE TECHNIQUE GUIDES INCLUDE A CAUTION STATING TO NEVER USE A FIXED OR RATCHETING T-HANDLE SCREWDRIVER FOR FINAL TIGHTENING OR LOOSENING/REMOVAL. SEVERAL ALTERNATIVE T25 DRIVERS ARE INCLUDED IN THE MATRIX SETS AS WELL. PRODUCT DRAWINGS WERE REVIEWED DURING THE INVESTIGATION. THE DRIVER IS DESIGNED WITH A T25 STARDRIVE TIP PER DESIGN STANDARD ES0182 AND IS MADE FROM HEAT TREATED X15TN. THE INSTRUMENT HAS BEEN VERIFIED TO WITHSTAND THE DESIGN REQUIREMENT OF 15NM TORQUE PER WINDCHILL DOCUMENT. THE RETURNED DRIVER WAS FOUND TO BE SLIGHTLY CHIPPED AT THE STARDRIVE LOBES. THE COMPLAINT DESCRIPTION STATES THAT THE SCREW DRIVER AND HOLDING SLEEVE FELL ON THE FLOOR AND WERE DAMAGED. BASED ON THE DESCRIPTION, IT IS CLEAR THAT THE BROKEN CONDITION IS DUE TO USER MISHANDLING AND NOT RELATED TO THE DESIGN OF THE PRODUCT. THE RETURNED DRIVER BROKE BECAUSE IT WAS DROPPED ON THE FLOOR. THE DESIGN OF THE INSTRUMENT WAS FOUND TO BE ADEQUATE. 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

    IT WAS REPORTED WHILE PUTTING TOGETHER A LONG-TERM LOANER SET FOLLOWING A PROCEDURE, AFTER THE PARTS HAD BEEN CLEANED, THE SCREW DRIVER AND HOLDING SLEEVE FELL ON THE FLOOR AND WERE DAMAGED. THE TIP OF THE SCREWDRIVER WAS THOUGHT TO BE BENT AND THE TIP OF THE HOLDING SLEEVE BROKE OFF. THE EVENT DID NOT OCCUR DURING SURGERY. IT WAS DISCOVERED DURING EVALUATION OF THE PRODUCT THAT THE TIP OF THE SCREWDRIVER WAS CHIPPED. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736774 T-HANDLE T25 STARDRIVE SHAFT F/MATRIX-LONG SREWDRIVERS HXX SYNTHES MONUMENT 6670699

    Patients

    Seq Age Sex Outcome Treatment
    1