BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-HANDLE T25 STARDRIVE SHAFT F/MATRIX-LONG

    MDR report key: 6537560 · Received May 2, 2017

    Report

    Report Number
    1719045-2017-10379
    Event Type
    Malfunction
    Date Received
    May 2, 2017
    Report Date
    April 6, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    UDI-DI
    10705034719184
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. PART #: 03.632.074, LOT#: 6457244 (NON-STERILE) - T-HANDLE T25 STARDRIVE SHAFT F/MATRIX - LONG. QUANTITY (B)(4). INCOMING INSPECTION MEET SPECIFICATION. UNIVERSAL PUNCH CERTIFICATE OF COMPLIANCE & CERTIFICATE OF TEST MEETS SPECIFICATION. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. MANUFACTURING LOCATION: SUPPLIER: (B)(4), PACKAGED BY: (B)(4). MANUFACTURING DATE: 29-APR-2011. 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

    A PRODUCT INVESTIGATION WAS COMPLETED: THE RETURNED INSTRUMENTS WERE EVALUATED AT CUSTOMER QUALITY AND THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED FOR ALL PARTS BUT 03.632.074 LOT 7901816. THE UNCONFIRMED SCREWDRIVER WAS RETURNED IN GOOD CONDITION WITH NO DAMAGE TO THE TIP. THE TIPS OF THE REMAINING SCREWDRIVERS WERE STRIPPED AS THE BLADES WERE DENTED IN AND PUSHED PROXIMALLY. ALTHOUGH THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE PROVIDED INFORMATION, IT IS LIKELY THAT EXCESSIVE FORCE OVER THE COURSE OF THE DEVICES¿ LIFE CONTRIBUTED TO THE COMPLAINT CONDITION. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. A VISUAL INSPECTION, DEVICE HISTORY RECORD (DHR) REVIEW, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THIS COMPLAINT IS CONFIRMED. REPLICATION OF THE COMPLAINT IS NOT APPLICABLE FOR THE COMPLAINT CONDITIONS. PER THE TECHNIQUE GUIDE, THE T-HANDLE T25 STARDRIVE SCREWDRIVERS ARE ONE OF TEN T25 DRIVER SHAFTS INTENDED TO BE UTILIZED FOR SCREW INSERTION IN THE MATRIX SYSTEM. OF THE TEN T25 DRIVERS AVAILABLE IN THE SYSTEM, ONLY FOUR ARE INTENDED FOR FINAL TIGHTENING (03.632.002, 03.632.072, 03.632.400 AND 03.632.401) WITH THE USE OF A 10NM TORQUE LIMITING RATCHET HANDLE (03.620.061) AND A COUNTERTORQUE (03.632.049). THE MATRIX DEFORMITY AND DEGENERATIVE TECHNIQUE GUIDES STATE TO ALWAYS USE THE TORQUE LIMITING HANDLE (03.620.061) TO REDUCE RISK OF DAMAGE TO THE T25 SCREWDRIVER SHAFT. THE TECHNIQUE ADDITION ALSO CAUTIONS TO NEVER USE A FIXED OR RATCHETING T-HANDLE SCREWDRIVER TO REMOVE LOCKING CAPS. IF THE TORQUE LIMITING ATTACHMENT IS NOT USED WHEN USING ANY OF THE STARDRIVE SHAFT OPTIONS, BREAKAGE OF THE DRIVER MAY OCCUR AND COULD POTENTIALLY HARM THE PATIENT. THE RELEVANT PRODUCT DRAWINGS WERE REVIEWED. THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THESE DEVICES. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE WHEN USED AND MAINTAINED AS RECOMMENDED, IT DID NOT CONTRIBUTE TO THE 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.

    Description of Event or Problem · 1

    IT IS REPORTED DURING ROUTINE INSPECTION OF DEVICES, THE TIPS OF THREE (3) MATRIX SCREWDRIVER SHAFTS WERE FOUND TO BE STRIPPED. NO PATIENT OR SURGICAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) MATRIX STARDRIVE SHAFT. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319538 T-HANDLE T25 STARDRIVE SHAFT F/MATRIX-LONG SCREWDRIVERS HXX SYNTHES MONUMENT 6457244 10705034719184

    Patients

    Seq Age Sex Outcome Treatment
    1