BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMORAL NECK SYSTEM INSERTION HANDLE

    MDR report key: 12704166 · Received October 27, 2021

    Report

    Report Number
    8030965-2021-09043
    Event Type
    Malfunction
    Date Received
    October 27, 2021
    Date of Event
    September 30, 2021
    Report Date
    September 30, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    UDI-DI
    07611819657342
    PMA / PMN Number
    K172872
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. INVESTIGATION SUMMARY VISUAL INSPECTION: THE COMPLAINT DEVICES INSERT HANDLE (PRODUCT CODE: 03.168.008, LOT NUMBER: 170435-105) WAS RETURNED TO CQ WEST CHESTER FOR INVESTIGATION. DURING VISUAL INSPECTION, NO ISSUES WERE IDENTIFIED ON THE RETURNED PART THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. FUNCTIONAL TEST: A FUNCTIONAL TEST COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED WITH A MATING DEVICE FOR EVALUATION. CAN THE COMPLAINT BE REPLICATED WITH THE RETURNED DEVICE(S)? NO, THE COMPLAINT CANNOT BE REPLICATED AS A FUNCTIONAL TEST COULD NOT BE PERFORMED. DOCUMENT/SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE, THE CURRENT AND MANUFACTURED VERSION OF DRAWING WERE REVIEWED. COMPLAINT CONFIRMED: NO, THE COMPLAINT CONDITION CANNOT BE CONFIRMED DURING PHYSICAL DEVICE INVESTIGATION. CONCLUSION: THE INSERTION INSTRUMENT WAS RETURNED WITHOUT A MATING DEVICE TO EVALUATE THE ALLEGATION, HENCE THE COMPLAINT WAS NOT CONFIRMED. A DEFINITIVE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. 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. DEVICE HISTORY LOT PART #: 03.168.008 LOT #: 170435-105 MANUFACTURING SITE: WERK SELZACH SUPPLIER: LEITNER AG RELEASE TO WAREHOUSE DATE: 30 AUG 2018 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. CORRECTED DATA: G1, H3, H6.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 THAT THE AIMING ARM SLIPPED OUT OF THE PLATE AFTER INSERTING THE FEMORAL NECK SYSTEM (FNS). THE LOCKING COMPRESSION PLATE (LCP) SCREW WAS RELEASED AND THE AIMING ARM CAME AWAY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A FIVE (5) MINUTE DELAY. CONCOMITANT DEVICE: UNK - PLATES: TRAUMA(PART# UNKNOWN, LOT# UNKNOWN, QTY UNKNOWN). THIS REPORT IS FOR ONE (1) FEMORAL NECK SYSTEM INSERTION HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1602720 FEMORAL NECK SYSTEM INSERTION HANDLE APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT SYNTHES GMBH 170435-105 07611819657342

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNK - PLATES: TRAUMA