BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DHS®/DCS® ONE-STEP LAG SCREW 12.7MM THREAD/105MM

    MDR report key: 4053376 · Received September 3, 2014

    Report

    Report Number
    3000270450-2014-10100
    Event Type
    Malfunction
    Date Received
    September 3, 2014
    Date of Event
    August 6, 2014
    Manufacturer
    SYNTHES SELZACH
    Product Code
    KTT
    PMA / PMN Number
    PK964259
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODE: JDO. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS LOT 5461427 OF DHS/DCS ONE STEP LAG SCREW WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE MANUFACTURING RECORDS FOR STERILE LOT 1709998 ARE NOT AVAILABLE AND HAVE NOT BEEN REVIEWED AT THE (B)(4) FACILITY. NO STERILITY EXPIRATION DATE IS AVAILABLE. 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 LAG SCREW HAD BEEN PLACED INTO THE PATIENTS FEMORAL HEAD (GOLD INSERTION WRENCH AND PLATE CONNECTED TO THE LAG SCREW WITH CONNECTION SCREW). IT WAS ALSO REPORTED THAT THE PLATE WOULD NOT SLIDE OVER THE WRENCH/COUPLING ONTO THE LAG SCREW. THE SURGEON WAS ABLE TO DO THIS OUTSIDE OF THE PATIENT AS IT WAS TESTED BEFORE HE INSERTED THE LAG SCREW ASSEMBLY IN THE PATIENT OVER THE WIRE. IT WAS DIFFICULT TO DETERMINE IF THIS WAS AN ISSUE CAUSED BY NOT POSITIONING THE T HANDLE INSERTION WRENCH IN LINE (PARALLEL) WITH THE PLATE SHAFT (FLOOR - PATIENT SUPINE) TO ALLOW THE PLATE TO GLIDE SMOOTHLY OVER THE COUPLING (ANTI-ROTATION BARREL OF THE WRENCH/SCREW). SURGEON WAS SURE HE HAD THE WRENCH IN THE CORRECT POSITION. THE HOSPITAL HAS DISPOSED OF THE IMPLANT (DHS PLATE AND SCREW) THAT DID NOT FUNCTION AS REQUIRED. THE T HANDLE INSERTION WRENCH WITH A PLATE WAS TESTED AND NO ISSUES WITH GLIDING OVER THE WRENCH. USED RICHARDS PIN AND PLATE AND THERE WERE NO ADVERSE PATIENT OUTCOME, BUT IT WAS A 20 MINUTE (SLIGHT DELAY IN THE PROCEDURE). THIS REPORT IS 3 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539358 DHS®/DCS® ONE-STEP LAG SCREW 12.7MM THREAD/105MM APPLIANCE,FIXATION,NAIL KTT SYNTHES SELZACH 1709998

    Patients

    Seq Age Sex Outcome Treatment
    1