BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DHS®/DCS® GUIDE SHAFT WITH FLATS

    MDR report key: 5365184 · Received January 13, 2016

    Report

    Report Number
    2520274-2016-10213
    Event Type
    Injury
    Date Received
    January 13, 2016
    Date of Event
    December 26, 2015
    Report Date
    December 27, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    FZX
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. (B)(4). 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.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). DEVICE IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. SUBJECT DEVICE HAS NOT BEEN RECEIVED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    PRODUCT INVESTIGATION SUMMARY: THE FOLLOWING COMPLAINT DEVICES WERE RECEIVED FOR EVALUATION: ONE DHS/DCS GUIDE SHAFT WITH FLATS (PART 338.23 / LOT NUMBER UNKNOWN); ONE DHS.DCS LAG SCREW 12.7MM THREAD/85MM (PART 280.850 / LOT NUMBER 7082641); ONE DHS/DCS WRENCH (PART 338.06 / LOT NUMBER 1070); THE RETURNED INSTRUMENTS ARE USED IN THE DHS/DCS DYNAMIC HIP AND CONDYLAR SCREW SYSTEM (TECHNIQUE GUIDE J3045-G). THE COMPLAINT CONDITION FOR THE DHS/DCS GUIDE SHAFT WAS LIKELY CAUSED BY THE USE OF THE EXCESSIVE TORQUE DURING SURGERY; HOWEVER, THIS COMPLAINT IS NOT LIKELY A RESULT OF ANY DESIGN RELATED DEFICIENCY. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE 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

    IT WAS REPORTED THAT ON (B)(6) 2005, DURING OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A HIP, A GUIDE SHAFT STRIPPED WHILE INSERTING A LAG SCREW. THE END OF THE LAG SCREW THEN BECAME DEFORMED AND THE DYNAMIC HIP SCREW (DHS) PLATE COULD NOT BE INSERTED OVER IT. A WRENCH WAS USED TO REMOVE IT, BUT WAS THEN STUCK ON THE LAG SCREW. A SECOND SET WAS OPENED TO PUT A NEW LAG SCREW IN AND THE PROCEDURE WAS COMPLETED. THE SAME PLATE WAS USED. THERE WAS A 30 MINUTE DELAY.THERE WERE NO FRAGMENTS LEFT IN THE PATIENT. THE PATIENT STATUS OUTCOME IS UNKNOWN. THE SURGERY WAS SUCCESSFULLY COMPLETED. THIS REPORT IS 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22831 DHS®/DCS® GUIDE SHAFT WITH FLATS GUIDE FZX SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention