BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLIDING MECHANISM

    MDR report key: 20065413 · Received August 26, 2024

    Report

    Report Number
    8030965-2024-10351
    Event Type
    Malfunction
    Date Received
    August 26, 2024
    Date of Event
    January 1, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTD
    UDI-DI
    10886982188779
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    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. H3, H4, H6: DEVICE HISTORY RECORD (DHR) REVIEW CONDUCTED: PRODUCT CODE: 314.291. LOT NUMBER: 170126-102. RELEASE TO WAREHOUSE DATE: 21.AUG.2017. EXPIRATION DATE: NA. SUPPLIER: (B)(4). MANUFACTURING SITE: WERK SELZACH. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. H3, H6: SERVICE AND REPAIR EVALUATION: THE CUSTOMER REPORTED THAT IT WAS REPORTED THAT ON UNKNOWN DATE THE INSTRUMENT HAVE BROKEN. THE REPAIR TECHNICIAN REPORTED THAT MISSING LEVER HOLDING SLIDING MECHANISM IN PLACE. THE ITEM IS NOT REPAIRABLE PER THE INSPECTION SHEET. THE CAUSE OF THE ISSUE IS FAULTY PARTS. THE ITEM WILL BE FORWARDED TO CUSTOMER QUALITY. THE EVALUATION WAS NOT CONFIRMED. 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

    IT WAS REPORTED THAT ON UNKNOWN DATE THE INSTRUMENT HAVE BROKEN. THERE WAS NO IMPACT ON SURGERY. THIS REPORT IS FOR ONE (1) SLIDING MECHANISM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1481895 SLIDING MECHANISM FORCEPS HTD SYNTHES GMBH 170126-102 10886982188779

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown