BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4MM STARDRIVE SCREWDRIVER SHAFT

    MDR report key: 6260613 · Received January 18, 2017

    Report

    Report Number
    3003875359-2017-10027
    Event Type
    Malfunction
    Date Received
    January 18, 2017
    Date of Event
    December 28, 2016
    Report Date
    December 28, 2016
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HXX
    UDI-DI
    10886982188847
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED. TWO (2) 2.4MM STARDRIVE SCREWDRIVER SHAFTS (PART 314.451 / LOTS 8831199 AND 9841750) WERE RECEIVED WITH THE COMPLAINT CATEGORY OF ¿BROKEN: INTRAOPERATIVELY. THE COMPLAINT CONDITION IS CONFIRMED AS THE TWO (2) SCREWDRIVER SHAFTS WERE EACH RECEIVED WITH THE PROXIMAL COUPLING BROKEN OFF. THE TRANSVERSE FRACTURE IS LOCATED AT THE PROXIMAL TRANSITION OF THE GROOVE. A DEVICE HISTORY RECORD (DHR) REVIEW, VISUAL INSPECTION, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. ONE (1) HANDLE WITH MINI QUICK COUPLING (PART 311.01 / LOT 7652521) WAS RETURNED AS A CONCOMITANT DEVICE WITHOUT AN ALLEGED COMPLAINT CONDITION. UPON VISUAL INSPECTION THERE IS NO EVIDENCE THAT THIS DEVICE CONTRIBUTED TO THE COMPLAINT CONDITION, AND THEREFORE NO ADDITIONAL INVESTIGATION WILL BE PERFORMED ON THIS DEVICE. THE TWO (2) SCREWDRIVER SHAFTS WERE EACH RECEIVED WITH THE PROXIMAL COUPLING BROKEN OFF. THE TRANSVERSE FRACTURE IS LOCATED AT THE PROXIMAL TRANSITION OF THE GROOVE. THE DISTAL STARDRIVE ON EACH DEVICE SHOWS SIGNIFICANT WEAR. THE COMPLAINT CONDITION IS CONFIRMED AND CONSISTENT WITH THE REPORTED CONDITION. REPLICATION OF THE COMPLAINT CONDITION IS NOT APPLICABLE AS THE DEVICES ARE ALREADY BROKEN. THE HANDLE WAS RECEIVED WITH THE QUICK COUPLING MECHANISM STUCK IN THE RETRACTED POSITION AND NOT TRAVELING UP AND DOWN AS INTENDED. FURTHER INSPECTION NOTED THAT THIS CONDITION IS DUE TO THE REPORTED ISSUE THAT "THE CONNECTION PORTION OF THE SCREWDRIVER SHAFT BROKE INSIDE THE HANDLE." THE PORTION CAN BE SEEN FROM THE DISTAL END OF THE CANNULATION. THERE IS NO EVIDENCE THAT THIS DEVICE CONTRIBUTED TO THE COMPLAINT CONDITION, AND THEREFORE NO ADDITIONAL INVESTIGATION WILL BE PERFORMED ON THIS DEVICE. THE 2.4MM STARDRIVE SCREWDRIVER SHAFT (314.541) IS AVAILABLE IN THE SCREW REMOVAL SYSTEM. RELEVANT DRAWINGS WERE REVIEWED. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED. THE BREAKS ARE CONSISTENT WITH EXPOSURE TO FORCE WHICH HAS EXCEEDED THE YIELD STRENGTH OF THE DEVICE. HOWEVER, THE ORIGIN OF THE FORCE WHICH RESULTED IN THIS DAMAGE IS UNKNOWN. 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.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. CONCOMITANT MEDICAL PRODUCTS: HANDLE WITH MINI QUICK COUPLING (PART # 311.01, LOT #7652521, QUANTITY 1). 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: PART#314.451 LOT# 9841750; MANUFACTURING LOCATION: (B)(4); MANUFACTURING DATE: 25.FEB.2016. 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 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 DURING A SCHEDULED HARDWARE REMOVAL CASE, TWO SCREWDRIVERS BROKE IN SURGERY DURING A HARDWARE REMOVAL CASE. THE CONNECTION PORTION OF THE SCREWDRIVER SHAFT BROKE INSIDE THE HANDLE, INCURRING A FIVE MINUTE DELAY TO SURGERY. THE HANDLE OF THE DEVICE BROKE. NO FRAGMENTS WERE GENERATED. THE SURGERY WAS SUCCESSFULLY COMPLETED. THIS COMPLAINT INVOLVES TWO (2) DEVICES. CONCOMITANT MEDICAL PRODUCTS: HANDLE WITH MINI QUICK COUPLING (PART # 311.01, LOT #7652521, QUANTITY 1). THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44714 2.4MM STARDRIVE SCREWDRIVER SHAFT SCREWDRIVERS HXX SYNTHES HAGENDORF 9841750 10886982188847

    Patients

    Seq Age Sex Outcome Treatment
    1