BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRAIGHT TIP T25 DRIVER-LONG

    MDR report key: 6167464 · Received December 12, 2016

    Report

    Report Number
    3003875359-2016-10647
    Event Type
    Malfunction
    Date Received
    December 12, 2016
    Report Date
    November 21, 2016
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HXX
    UDI-DI
    10705034719924
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS COMPLETED: THE RETURNED DRIVER WAS EXAMINED AND THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED AS THE DRIVER TIP WAS FOUND TO BE BROKEN; FRAGMENT NOT RETURNED (APPROXIMATELY 3.5MM TALL X 4.5MM DIAMETER). NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED; THE FAILURE MODE IS CONSISTENT WITH INCORRECT TECHNIQUE/APPLICATION OF EXCESSIVE FORCE. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. A VISUAL INSPECTION, DRAWING REVIEW AND COMPLAINT HISTORY REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THIS COMPLAINT IS CONFIRMED. PER THE TECHNIQUE GUIDE, THE STRAIGHT TIP T25 DRIVER-LONG (03.632.401) IS ONE OF FOUR T25 DRIVER SHAFTS INTENDED TO BE UTILIZED IN FINAL LOCKING TAP TIGHTENING FOR THE MATRIX SYSTEM (03.632.002, 03.632.072, 03.632.400 AND 03.632.401). PROPER TECHNIQUE INCLUDES THE USE OF A 10NM TORQUE LIMITING RATCHET HANDLE (03.620.061) AND A COUNTERTORQUE (03.632.049). THE FOLLOWING CAUTION IS NOTED: ¿NEVER USE FIXED OR RATCHETING T-HANDLE SCREWDRIVER FOR THIS TECHNIQUE. 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.¿ RELEVANT DRAWINGS FOR THE RETURNED INSTRUMENT WERE REVIEWED. THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THESE DEVICES. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE RETURNED INSTRUMENT¿S LOT NUMBER AND NO MATERIAL REVIEW REPORTS, NON-CONFORMANCE REPORTS OR COMPLAINT-RELATED ISSUES WERE IDENTIFIED WITH THE LOT NUMBER WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED; THE FAILURE MODE IS CONSISTENT WITH INCORRECT TECHNIQUE/APPLICATION OF EXCESSIVE FORCE. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. CATALOG AND UDI NUMBER 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

    ADDITIONAL NARRATIVE: THERE WAS NO KNOWN REPORTED PATIENT INVOLVEMENT ASSOCIATED WITH THE COMPLAINED EVENT. DATE OF EVENT IS UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PART #03.632.401, LOT #9492779: MANUFACTURING SITE: (B)(4), MANUFACTURING DATE: JUNE 26, 2015: NO NON-CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. 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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE PART #03.632.401, LOT #9324003. MANUFACTURING LOCATION: (B)(6). DATE OF MANUFACTURE: FEBRUARY 20,2015 THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. 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 THAT THE TIP OF A STARDRIVE SCREWDRIVER WAS FOUND BROKEN OFF DURING INSPECTION OF THE SET. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4)..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817416 STRAIGHT TIP T25 DRIVER-LONG SCREWDRIVERS HXX SYNTHES HAGENDORF 9324003 10705034719924

    Patients

    Seq Age Sex Outcome Treatment
    1