BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE SCREWDRIVER SHAFT T8 55MM

    MDR report key: 10885108 · Received November 23, 2020

    Report

    Report Number
    2939274-2020-05268
    Event Type
    Malfunction
    Date Received
    November 23, 2020
    Date of Event
    October 27, 2020
    Report Date
    October 27, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10886982188854
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10: ADDITIONAL NARRATIVE: H3, H4, H6: PART 314.453, LOT 3172926: MANUFACTURING SITE: HÄGENDORF. RELEASE TO WAREHOUSE DATE: MAY 28, 2009. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. H3, H6: A PRODUCT INVESTIGATION WAS COMPLETED: VISUAL INSPECTION OF THE COMPLAINT DEVICE SHOWED THE DISTAL TIP WAS STRIPPED. THE CONDITION OF THE DEVICE IS CONSISTENT AS AN END OF LIFE INDICATOR FOR THE DEVICE. NO OTHER ISSUES WERE IDENTIFIED DURING INSPECTION. THE RECEIVED CONDITION IS CONSISTENT WITH THE COMPLAINT CONDITION THUS THE COMPLAINT IS CONFIRMED. IT IS DETERMINED THAT THE REUSABLE INSTRUMENT IS WORN FROM REPEATED USE AND SERVICING; THEREFORE, FURTHER INVESTIGATION FOR THE REPORTED COMPLAINT DEVICE IS NOT REQUIRED. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION; THEREFORE, FURTHER CORRECTIVE AND/OR PREVENTIVE ACTION IS NOT REQUIRED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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

    THE DEVICE HAS BEEN RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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 ON (B)(6) 2020, DURING FIXATION OF OLECRANON, THE STARDRIVE SCREWDRIVER SHAFT T8 55MM AND TORQUE LIMITING ATTACHMENT WOULD NOT PROVIDE APPROPRIATE TIGHTENING FEEDBACK ON VARIABLE ANGLE LOCKING SCREWS. THE SURGEON USED NON TLA SCREWDRIVER FOR FINAL TIGHTENING. THERE WAS A SURGICAL DELAY OF 2 MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS AS PLANNED. CONCOMITANT DEVICES REPORTED: TORQUE LIMITING ATTACHMENT 1.2NM (PART # 03.110.002, LOT # 1008217, QUANTITY 1), LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 5). THIS REPORT IS FOR 1 STARDRIVE SCREWDRIVER SHAFT T8 55MM. THIS IS REPORT 1 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1350725 STARDRIVE SCREWDRIVER SHAFT T8 55MM SCREWDRIVER HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 314.453 3172926 10886982188854

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR TORQUE LIMITING ATTACHMENT 1.2NM| UNK - SCREWS: LOCKING| UNK - SCREWS: LOCKING| UNK - SCREWS: LOCKING| UNK - SCREWS: LOCKING| UNK - SCREWS: LOCKING| TORQUE LIMITING ATTACHMENT 1.2NM| UNK - SCREWS: LOCKING| UNK - SCREWS: LOCKING| UNK - SCREWS: LOCKING| UNK - SCREWS: LOCKING| UNK - SCREWS: LOCKING