BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE SCREWDRIVER SHAFT T15/SELF-RETAINING QC

    MDR report key: 6811931 · Received August 22, 2017

    Report

    Report Number
    1719045-2017-10817
    Event Type
    Malfunction
    Date Received
    August 22, 2017
    Report Date
    August 3, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    UDI-DI
    10705034714905
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INVOLVEMENT WAS REPORTED. 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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DHR REVIEW FOR PART # 03.614.019, SYNTHES LOT # 6070267. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. RELEASE TO WAREHOUSE DATE: 08-MAY-2009. SUPPLIER: (B)(4). MANUFACTURED BY SYNTHES (B)(4). 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (STARDRIVE SCREWDRIVER SHAFT T15/SELF-RETAINING QC, PART NUMBER 03.614.019, LOT NUMBER 6070267). THE SUBJECT DEVICE WAS RETURNED WITH THE COMPLAINT CONDITION STATING: IT WAS REPORTED THAT TWO T15 SELF-RETAINING STARDRIVE SCREWDRIVER SHAFTS HAVE WORN TIPS. THIS WAS DISCOVERED DURING ROUTINE INSPECTION. THE AGE OF THE DEVICES IS SUSPECTED TO BE APPROXIMATELY 10 YEARS. NO PROCEDURE OR PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (2) PARTS. THE FOLLOWING PARTS WERE RETURNED AND RECEIVED AT CQ: PART #03.614.019 STARDRIVE SCREWDRIVER SHAFT T15/SELF-RETAINING QC. LOT #6070267, QTY : 2. TWO (2) 03.614.019, LOT NUMBER 6070267, STARDRIVE SCREWDRIVER SHAFTS WERE RETURNED WITH STRIPPED TIPS. THIS COMPLAINT IS CONFIRMED. THE STARDRIVE TIPS OF BOTH INSTRUMENTS WERE RETURNED STRIPPED. A VISUAL INSPECTION UNDER 5X MAGNIFICATION, DHR REVIEW, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. WHETHER THIS COMPLAINT CAN BE REPLICATED AT CUSTOMER QUALITY (CQ) IS NOT APPLICABLE FOR THIS COMPLAINT CONDITION AS THE RETURNED DEVICES ARE ALREADY STRIPPED. THE 03.614.019 STARDRIVE SCREWDRIVER SHAFT T15 IS UTILIZED IN THE SYNAPSE OCT SYSTEM FOR POSTERIOR STABILIZATION OF THE UPPER SPINE. THE DRIVER IS SPECIFICALLY UTILIZED TO INSERT/FINAL TIGHTEN LOCKING SCREWS. THE DEVICE WAS RETURNED AND IT WAS REPORTED THAT "TWO T15 SELF-RETAINING STARDRIVE SCREWDRIVER SHAFTS HAVE WORN TIPS." THIS CONDITION IS CONFIRMED; TWO (2) 03.614.019, LOT NUMBER 6070267, STARDRIVE SCREWDRIVER SHAFTS WERE RETURNED WITH STRIPPED TIPS. THE STARDRIVE TIPS OF BOTH INSTRUMENTS WERE RETURNED STRIPPED. THE BALANCE OF THE RETURNED DEVICES ARE IN FAIRLY WORN CONDITION, THE TWO INSTRUMENTS ARE DISCOLORED AND SCRATCHES ARE PRESENT ALONG THEIR LENGTHS. THE INSTRUMENTS ARE USED TO INSERT/FINAL TIGHTEN SCREWS. ALTHOUGH A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, IT IS LIKELY THAT THIS COMPLAINT CONDITION WAS DUE TO CONSISTENT USE AND CUMULATIVE WEAR OVER THE PARTS' LIFETIME, CAUSING THE TIPS TO STRIP. DRAWING WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. THE INSTRUMENTS ARE USED TO INSERT/FINAL TIGHTEN SCREWS. ALTHOUGH A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, IT IS LIKELY THAT THIS COMPLAINT CONDITION WAS DUE TO CONSISTENT USE AND CUMULATIVE WEAR OVER THE PARTS' LIFETIME, CAUSING THE TIPS TO STRIP. 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 TWO (2) T15 SELF-RETAINING STARDRIVE SCREWDRIVER SHAFTS HAVE WORN TIPS. THIS WAS DISCOVERED DURING ROUTINE INSPECTION. NO PROCEDURE OR PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) T15 STARDRIVE SCREWDRIVER SHAFT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591566 STARDRIVE SCREWDRIVER SHAFT T15/SELF-RETAINING QC SCREWDRIVERS HXX SYNTHES MONUMENT 6070267 10705034714905

    Patients

    Seq Age Sex Outcome Treatment
    1