BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DHS®/DCS® LAG SCREW 12.7MM THREAD/95MM-STERILE

    MDR report key: 5653662 · Received May 13, 2016

    Report

    Report Number
    3009450863-2016-10013
    Event Type
    Malfunction
    Date Received
    May 13, 2016
    Date of Event
    April 20, 2016
    Report Date
    April 20, 2016
    Manufacturer
    SYNTHES BALSTHAL
    Product Code
    KTT
    PMA / PMN Number
    PK791619
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. UDI: (B)(4). INITIAL REPORTER: REPORTING FACILITY PHONE NUMBER IS (B)(6). REPORTER¿S LAST NAME WAS NOT PROVIDED. THIS DEVICE WAS NOT IMPLANTED IN THE PATIENT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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

    REPORT WAS INITIALLY SUBMITTED ON JUN 24, 2016 BUT THE REPORT DID NOT PASS THE FIRST ACKNOWLEDGEMENT IN THE FDA PORTAL. ADVISED BY FDA ON JUN 30, 2016 TO RESUBMIT MEDWATCH. DEVICE WAS NOT IMPLANTED/EXPLANTED. A PRODUCT INVESTIGATION WAS COMPLETED: RECEIVED PARTS: SCREW (PART 280.950S, LOT NUMBER 8590276) AND PLATE (PART 02.224.205S, LOT NUMBER 8002687). THE POSITIONING GROOVE OF THE DHS/DCS SCREW IS EXPANDED AND DAMAGED. THE PLATE SHOWS SCRATCHES ALL OVER ON THE SURFACE. NO SIGNIFICANT DAMAGE VISIBLE. THE DIMENSIONS OF THE DHS/DCS SCREW, WHICH ARE RELEVANT FOR THE COMPLAINT CONDITION AS FAR AS POSSIBLE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS. THE OUTSIDE DIAMETER IS WITHIN TOLERANCE. DUE TO THE DAMAGES NO FURTHER DIMENSION COULD BE MEASURED. THE DEVICE HISTORY RECORD REVIEW SHOWS THAT THE CORRECT MATERIAL AND MANUFACTURING PROCEDURES WERE USED. THE EXAMINATION OF THE RAW-MATERIAL TESTING CERTIFICATE SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE SPECIFICATIONS AND INTERNATIONAL STANDARDS. THERE WAS LIMITED INFORMATION IN THE COMPLAINT DESCRIPTION AND THEREFORE HOW THE COMPLAINT CONDITION HAPPENED CANNOT BE CONFIRMED. IT IS LIKELY THAT THE CONNECTION BETWEEN THE WRENCH AND THE SCREW WAS NOT ALIGNED AS INTENDED AND THEREFORE THIS OCCURRENCE IN COMBINATION WITH A MECHANICAL OVERLOAD SITUATION COULD LED TO THE COMPLAINT CONDITION. NO PRODUCT FAULT COULD BE FOUND. 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

    SYNTHES (B)(4) REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2016, THE DYNAMIC HIP SYSTEM SCREW (DHS) DID NOT FIT IN THE HOLE OF THE LOCKING COMPRESSION DHS PLATE. A DIFFERENT PLATE AND SCREW WERE USED TO COMPLETE THE PROCEDURE. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO REPORTED DELAY AND NO HARM TO THE PATIENT. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    CONCOMITANT REPORTED PARTS: LOCKING COMPRESSION PLATE (PART 02.224.205S, LOT 8002687, QUANTITY 1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307538 DHS®/DCS® LAG SCREW 12.7MM THREAD/95MM-STERILE APPLIANCE, FIXATION, NAIL KTT SYNTHES BALSTHAL 8590276

    Patients

    Seq Age Sex Outcome Treatment
    1