BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DHS/DCS ONE-STEP LAG SCREW 12.7MM THREAD/90MM

    MDR report key: 12543678 · Received September 28, 2021

    Report

    Report Number
    8030965-2021-08102
    Event Type
    Malfunction
    Date Received
    September 28, 2021
    Report Date
    September 2, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K964259
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PART #: 280.29 LOT #: 6533836 MANUFACTURING SITE: (B)(4), SUPPLIER: SYNTHES USA HQ, INC, RELEASE TO WAREHOUSE DATE: 29 NOV 2010. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE DHS/DCS-SCR Ø12.5 L90 OCTAGONAL-COUPL SS (PART #: 280.29, LOT #: 6533836) WAS RECEIVED AT US CUSTOMER QUALITY (CQ). VISUAL INSPECTION SHOWED THAT THE DEVICE WAS SEVERELY SCRATCHED AND NICKED. IT WAS ALSO OBSERVED TO BE SLIGHTLY DEFORMED AT THE PROXIMAL END AROUND THE HOLE. FUNCTIONAL TEST: DURING FUNCTIONAL ASSESSMENT, THE DEVICE WAS ASSEMBLED WITH ITS MATING DEVICE (THE SECOND RETURNED DEVICE). BOTH DEVICES STUCK TOGETHER BUT AFTER WIGGLING AND PULLING IN OPPOSITE DIRECTIONS BOTH DEVICES; THEY CAME APART; HENCE THIS COMPLAINT IS CONFIRMED. CAN THE COMPLAINT BE REPLICATED WITH THE RETURNED DEVICE? YES. DIMENSIONAL INSPECTION: MEASURED DIMENSIONS, FLAT DIAMETER: CONFORM, ROUND DIAMETER: CONFORM. DOCUMENT/SPECIFICATION REVIEW: CURRENT AND MANUFACTURED WERE REVIEWED. NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. COMPLAINT CONFIRMED? YES. INVESTIGATION CONCLUSION: THIS COMPLAINT IS CONFIRMED AS THE DEVICE WAS SEVERELY SCRATCHED AND NICKED. IT WAS ALSO OBSERVED TO BE SLIGHTLY DEFORMED AT THE PROXIMAL END AROUND THE HOLE. THIS CONDITION OF THE DEVICE CONTRIBUTED TO THE REPORTED CONDITION OF JAMMED/SEIZED. NO ROOT CAUSE COULD DEFINITIVELY BE DETERMINED FOR THE REPORTED COMPLAINT CONDITION. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTIVE ACTION IS PROPOSED. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT THE DHS WRENCH STILL HAD A DHS IMPLANT FROM THE PREVIOUS CASE STUCK ON THE WRENCH. THE JAMMED LAG SCREW WAS REMOVED FROM THE WRENCH SO THAT THE WRENCH COULD BE USED TO REMOVE THE DHS SCREW IN THE PATIENT ON THE TABLE. THE PRIMARY IMPLANTATION HAPPENED COUPLE OF YEARS AGO. THE BONE HAD UNITED WELL. THERE IS NO ALLEGATION AGAINST THE IMPLANTS. THE PATIENT EXPERIENCED SLIGHT SOFT TISSUE IRRITATION (NO INFECTION ) WHICH WAS VERY COMMON AND OPTED TO REMOVE THE IMPLANTS (DHS DYNAMIC HIP SCREW) AND 7.3MM CANNULATED SCREW) ON (B)(6) 2021. THE IMPLANTS WERE INTACT AFTER REMOVAL. THERE WAS NO ADVERSE EVENT TO PATIENT. THERE WAS NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) DHS/DCS ONE-STEP LAG SCREW 12.7MM THREAD/90MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1437900 DHS/DCS ONE-STEP LAG SCREW 12.7MM THREAD/90MM APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT SYNTHES GMBH 6533836

    Patients

    Seq Age Sex Outcome Treatment
    1