BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVER SHAFT 2.4 SHORT SELF-HOLDING F

    MDR report key: 16296561 · Received February 3, 2023

    Report

    Report Number
    8030965-2023-01377
    Event Type
    Malfunction
    Date Received
    February 3, 2023
    Date of Event
    January 13, 2023
    Report Date
    February 3, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    UDI-DI
    07611819831384
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. PART: 314.453, LOT: 9853856, RELEASE TO WAREHOUSE DATE: 02 MAY 2016, MANUFACTURING SITE: WERK HÄGENDORF, EXPIRATION DATE: N/A. THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT SCRDRIVER SHAFT 2.4 SHORT SELF-HOLDING F WAS STRIPPED FROM THE TIP. THE OBSERVED CONDITION WAS CONSISTENT AS AN END OF LIFE INDICATOR FOR THE DEVICE. NO OTHER ISSUES WERE IDENTIFIED. AFTER A VISUAL INSPECTION PER PROCEDURE, IT WAS DETERMINED THAT THE REUSABLE INSTRUMENT DEVICE WAS STRIPPED FROM REPEATED USE AND SERVICING; THEREFORE, FURTHER INVESTIGATION FOR THE REPORTED COMPLAINT DEVICE IS NOT REQUIRED. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITON OF SCRDRIVER SHAFT 2.4 SHORT SELF-HOLDING F WOULD HAVE CONTRIBUTED TO THE COMPLAINED ISSUE. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. IT WAS DETERMINED THAT THE REUSABLE INSTRUMENT WAS WORN FROM REPEATED USE AND SERVICING. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THIS MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). 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. THE SUBJECT 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 · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT ORIF FOR DISTAL HUMERUS FRACTURE WITH THE SCREWDRIVER SHAFT IN QUESTION. WHEN THE SURGEON ATTEMPTED TO APPLY TORQUE ACCORDING TO THE MANUAL, THE SCREW HEAD COULD NOT BE LOCKED CORRECTLY. UPON CHECKING THE TIP OF THE SCREWDRIVER, IT WAS DISCOVERED THAT THE TIP WAS SEVERELY WORN. HE USED 314.467 AS AN ALTERNATIVE AND WAS ABLE TO LOCK IT IN ONE SHOT WHEN HE APPLIED THE TORQUE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. TIP WEAR HAS BEEN NOTED AND A REQUEST HAS BEEN RECEIVED FOR A REVIEW OF THE INSPECTION AT THE TIME OF SHIPMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE(1) DEVICE. THIS REPORT IS FOR ONE (1) SCRDRIVER SHAFT 2.4 SHORT SELF-HOLDING F THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2104950 SCRDRIVER SHAFT 2.4 SHORT SELF-HOLDING F SCREWDRIVER HXX SYNTHES GMBH 9853856 07611819831384

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown