BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DHS®/DCS® LAG SCREW 14.0MM THREAD/95MM-STERILE

    MDR report key: 4399870 · Received January 8, 2015

    Report

    Report Number
    1719045-2015-10020
    Event Type
    Malfunction
    Date Received
    January 8, 2015
    Date of Event
    December 12, 2014
    Report Date
    December 12, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    KTT
    PMA / PMN Number
    PK791619
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. A MANUFACTURING EVALUATION WAS PERFORMED. THE SCREW WAS FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS. THE EXAMINATION OF THE RAW MATERIAL TESTING CERTIFICATES AND THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH, AND STRUCTURAL STABILITY. THE DEVICE WAS NOTED TO HAVE A WIDENED POSITION GROOVE. OUR INVESTIGATIONS HAVE SHOWN THAT THE POSITIONING GROOVE OF THE SCREW HAS BEEN WIDENED UP DUE TO INADEQUATE HANDLING. THE GROOVE IS EXPANDED AND DAMAGED AND THEREFORE THE PLATE DOES NOT PASS THE SLOTTED END OF THE SCREW. NO PRODUCT FAULT COULD BE DETECTED. 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

    PATIENT IDENTIFYING INFORMATION IS NOT AVAILABLE FOR REPORTING. THE SCREW BROKE INTRAOPERATIVELY AND WAS NOT IMPLANTED OR EXPLANTED. COMPLAINANT PART WAS RECEIVED BY MANUFACTURER FOR REVIEW/INVESTIGATION ON (B)(4) 2014. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN. DEVICE HISTORY REVIEW: LOT 9080382 - MANUFACTURING LOCATION: (B)(4) - MANUFACTURING DATE: JULY 14, 2014 - EXPIRY DATE: JULY 1, 2024. THIS COMPLAINT IS ASSESSED AS NOT RELATED TO STERILIZATION. THUS, THE DOCUMENTS FOR THE CORRESPONDING NON-STERILE PART, LOT 9160241, WERE REVIEWED WITH THE FOLLOWING RESULT: NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE DYNAMIC HIP SYSTEM (DHS) SCREW (14MM) DID NOT FIT IN TO THE BARREL OF A LOCKING COMPRESSION DHS PLATE. A NEW SCREW WAS USED AND THE PROCEDURE WAS COMPLETED. A FIVE MINUTE SURGICAL DELAY WAS NOTED. NO PATIENT HARM REPORTED. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14757 DHS®/DCS® LAG SCREW 14.0MM THREAD/95MM-STERILE APPLIANCE, FIXATION, NAIL KTT SYNTHES MONUMENT 9080382

    Patients

    Seq Age Sex Outcome Treatment
    1