BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DHS®/DCS® INSERTION WRENCH

    MDR report key: 4151553 · Received October 8, 2014

    Report

    Report Number
    3003875359-2014-10304
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 6, 2014
    Report Date
    September 12, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HXC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: THE INSTRUMENTS WERE RECEIVED VISUALLY CLEAN BUT BROKEN. ACCORDING TO THE COMPLAINT REPORT THE INSERTION OF THE DYNAMIC HIP SCREW (DHS) WAS PERFORMED WITHOUT THE CENTERING SLEEVE (ARTICLE 338.320) WHEREAS THE SURGICAL TECHNIQUE GUIDE INCLUDES THE CENTERING SLEEVE. THE CENTERING SLEEVE PROVIDES MORE STABILITY BETWEEN THE WRENCH AND THE DHS SCREW AND COULD REDUCE THE RISK OF BREAKAGE OF THE CONNECTION SCREW. NEVERTHELESS, BASED ON THE PROVIDED INFORMATION, THE MATERIAL AND THE LOW OCCURRENCE RATE A DESIGN RELATED ISSUE CAN BE EXCLUDED. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: 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

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS WAS COMPLETED: A NON-CONFORMANCE REPORT WAS GENERATED DURING PRODUCTION, INDICATING THAT IN MORE THAN HALF OF THE PIECES OF THIS LOT, THE SURFACE COLOR WAS GREYISH-DULL INSTEAD OF SILVER-GLOSSY; 19 OF 30 PIECES WERE SEPARATED OUT. IT ALSO INDICATES THAT TWO WRONG MATERIALS WERE USED AND ONE OF THEM WAS RELEASED. 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

    A MANUFACTURING EVALUATION WAS COMPLETED: SLIGHT SCRATCHES ON THE SHAFT FROM T-HANDLE. THE T-HANDLE IS BROKEN INTO TWO PARTS. THE T-HANDLE IS BROKEN IN THE AREA OF THE WELD SEAM BETWEEN THE FRONT AND REAR PART. OUTSIDE THREAD FROM THE REAR PART BROKE OFF IN THE AREA Ø5.96MM. DIAMETER IS STILL MEASURABLE. REAR PART IS MADE OUT OF (B)(4) .THE BROKEN THREAD WAS NOT SUPPLIED. WHY THE OUTSIDE THREAD BROKE OFF COULD NOT BE FOUND. DUE TO THE MISSING THREAD, FURTHER INVESTIGATION COULD NOT PERFORMED. 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 SYNTHES EUROPE REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE HANDLE AND CONNECTION SCREW BROKE DURING THE INSERTION OF THE SCREW WITH THE PLATE FOR A FEMUR FRACTURE CASE. IT WAS REPORTED THAT THE BONE QUALITY OF THE PATIENT WAS GOOD. DURING THE LAST TURN OF THE HANDLE WHILE GETTING IT HORIZONTAL, THE THREADED PIN OF THE CONNECTION SCREW BROKE AND THE WHOLE THING FELL APART. THE CONNECTION SCREW WAS TAKEN OUT AND THE HANDLE WAS PUT BACK IN WITH THE PLATE IN AN ATTEMPT TO INSERT THE PLATE; HOWEVER THE ALIGNMENT WASN¿T CORRECT, SO THE SURGEON DECIDED TO REMOVE THE SCREW USING ONLY THE HANDLE (NO CONNECTION SCREW). WHILE REMOVING THE SCREW, THE HANDLE FRACTURED BETWEEN THE WELD AND ALSO THE THREAD AS WELL. THE HANDLE HAD COME APART IN A PREVIOUS CASE, BUT IT WAS ABLE TO BE PUT BACK TOGETHER THEN BECAUSE THE THREADS COULD STILL BE CONNECTED. HOWEVER, IN THIS PROCEDURE, THE WHOLE THREAD HAD BROKEN OFF AS WELL. THIS IS REPORT 2 OF 2 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633496 DHS®/DCS® INSERTION WRENCH WRENCH HXC SYNTHES HAGENDORF 1956634

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR