BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM HEX SCREWDRIVER

    MDR report key: 6905757 · Received September 29, 2017

    Report

    Report Number
    9680938-2017-10134
    Event Type
    Malfunction
    Date Received
    September 29, 2017
    Report Date
    September 13, 2017
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HXX
    UDI-DI
    10705034731803
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. NO PATIENT INVOLVEMENT REPORTED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DATE RETURNED TO MANUFACTURER. ADDITIONAL REPORTER'S PHONE NUMBER: (B)(6). SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING DATE: 27-JUL-2008 (25 PARTS) AND 08-SEP-2008 (76 PARTS). EXPIRATION DATE: NA. REVIEW OF THE DEVICE HISTORY RECORD OF TUTTLINGEN SHOWED THAT THERE WERE NO ISSUES AT THE TIME OF MANUFACTURING OF THIS DEVICE THAT WOULD CONTRIBUTE TO THE ISSUE OUTLINED IN THIS COMPLAINT. A REVIEW OF INSPECTION RECORDS AND CERTIFICATIONS, CONFIRM THAT THE, HARDNESS TESTING AND FINAL PRODUCT MET INSPECTION RECORDS, CERTIFICATION. ALL 101 PARTS OF THE LOT WERE CHECKED 100% FOR IMPORTANT FEATURES AT THE FINAL INSPECTION ON 20-JUN-2008. 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 PERFORMED. THE RETURNED SCREWDRIVER WAS EXAMINED AND THE COMPLAINT CONDITION COULD BE CONFIRMED AS THE DISTAL TIP WAS FOUND TO BE BROKEN AND MISSING A SEGMENT WHICH WAS FOUND RETAINED WITHIN THE DRIVE RECESS OF THE RETURNED TRIAL IMPLANT. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED AS METHOD OF USE AT TIME OF FAILURE IS UNKNOWN. THE REMAINING DISTAL TIP OF THE SHAFT SHOWS TWISTING CONSISTENT WITH TIGHTENING, AS SUCH IT IS LIKELY TO EXCESSIVE FORCE WAS APPLIED CAUSING THE DEVICE TO DEFORM AND THEN FAIL. THE COMPLAINT CONDITION WAS UNABLE TO BE REPLICATED DUE TO POST-MANUFACTURING DAMAGE. THE TRIAL IMPLANT WAS FOUND TO BE INTACT AND WITHOUT IDENTIFIABLE DEFECT OR DEFICIENCY. NO FURTHER INVESTIGATION WILL BE COMPLETED AS THE COMPLAINT ALLEGATION RELATED TO THE TRIAL IS UNCONFIRMED. A VISUAL INSPECTION, DRAWING REVIEW AND DEVICE HISTORY REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THIS COMPLAINT IS CONFIRMED. THE 2.0MM HEX SCREWDRIVER (03.820.143) IS A COMPONENT OF THE PRODISC-C INSTRUMENT AND IMPLANT SET (01.820.003) WHICH IS UTILIZED FOR SINGLE LEVEL SPINAL ARTHROPLASTY FROM C3-C7. THE SCREWDRIVER IS UTILIZED DURING TRIALING TO BACK OUT THE TRIAL STOP, ALLOWING THE TRIAL TO ADVANCE MORE POSTERIORLY. RELEVANT DRAWINGS FOR THE RETURNED DEVICE WERE REVIEWED. THE FOLLOWING DIMENSIONAL ANALYSIS WAS COMPLETED: APPROXIMATELY 2MM OF THE DISTAL TIP WAS FOUND TO BE BROKEN AND NOT RETURNED. LENGTH OF SHAFT FROM THE RADIUS WHICH INTERACTS WITH THE HANDLE TO THE TIP IS 118MM PER RELEVANT DRAWING. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED 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

    THE SERVICE AND REPAIRS DEPARTMENT DOCUMENTED THAT THE TIP IS BROKE IN A TRIAL IMPLANT EXTRA LARGE DEEP. ALSO, THE TIP IS BROKEN ON A 2.0MM HEX SCREWDRIVER. BOTH ISSUES WERE FOUND DURING INSPECTION OF A SET. BOTH ITEMS ARE NON-REPAIRABLE. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWO DEVICES. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685490 2.0MM HEX SCREWDRIVER SCREWDRIVERS HXX SYNTHES TUTTLINGEN T927427 10705034731803

    Patients

    Seq Age Sex Outcome Treatment
    1