BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVER SHAFT T8 SELF-HOLD

    MDR report key: 12177847 · Received July 15, 2021

    Report

    Report Number
    8030965-2021-05810
    Event Type
    Malfunction
    Date Received
    July 15, 2021
    Date of Event
    June 15, 2021
    Report Date
    June 15, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    UDI-DI
    07611819775459
    PMA / PMN Number
    K152239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. H3, H6: INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO US CQ FOR EVALUATION. THE US CQ TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT SCRDRIVER SHAFT T8 SELF-HOLD THE TIP OF THE SCREWDRIVER IS DEFORMED. NO OTHER ISSUES WERE IDENTIFIED. THE DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO THE POST MANUFACTURING DAMAGE. THE OBSERVED CONDITION OF SCRDRIVER SHAFT T8 SELF-HOLD IN THE DEVICE WAS CONSISTENT. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED FOR SCRDRIVER SHAFT T8 SELF-HOLD. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED, THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. 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. DRAWING/SPECIFICATIONS REVIEWED: RELATED DRAWINGS ARE REFLECTING THE CURRENT AND MANUFACTURE REVISION WAS REVIEWED. DEVICE HISTORY LOT PART #: 314.467. LOT #: 6248585. MANUFACTURING SITE: SELZACH. SUPPLIER: SYNTHES USA HQ, INC . RELEASE TO WAREHOUSE DATE: FEB 02, 2010. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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

    PRODUCT COMPLAINT #: (B)(4). ADDITIONAL PRODUCT CODE: KWQ, NKG. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/ INVESTIGATION BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION SURGERY FOR DISTAL HUMERUS FRACTURE. DURING THE SURGERY, WHEN THE SURGEON TRIED TO LOCK THE 3 LOCKING SCREWS, THE 3 LOCKING SCREWS GOT STRIPPED AND HE COULDN¿T LOCK THEM. THE SURGEON MANAGED TO REMOVE THE 3 LOCKING SCREWS AND INSERTED NEW LOCKING SCREWS WITH ANOTHER SCREWDRIVER WITHOUT ANY PROBLEMS. IT WAS CONFIRMED THAT THERE WAS NO METALLIC DEBRIS LEFT INSIDE THE BODY DUE TO THE LOCKING SCREWS BEING STRIPPED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR (1) SCRDRIVER SHAFT T8 SELF-HOLD. THIS REPORT IS 4 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1069896 SCRDRIVER SHAFT T8 SELF-HOLD SCREWDRIVERS HXX SYNTHES GMBH 6248585 07611819775459

    Patients

    Seq Age Sex Outcome Treatment
    1 SCRDRIVER SHAFT 2.4 SHORT SELF-HOLD| SCRDRIVER SHAFT T8 SELF-HOLD| VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L14 TA| VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L16 TA| VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L18 TA