BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRA CURVED BROACH HANDLE

    MDR report key: 9937791 · Received April 8, 2020

    Report

    Report Number
    1818910-2020-10419
    Event Type
    Malfunction
    Date Received
    April 8, 2020
    Report Date
    March 13, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HTQ
    UDI-DI
    10603295148531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: EXAMINATION OF THE RETURNED INSTRUMENT FOUND THE ALLEGED COMPLAINT UNCONFIRMED BUT FOUND A DIFFERENT FAILURE UPON INSPECTION OF THE INSTRUMENT. DEPUY-SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED, AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. TERRITORY 139 REPORTED THAT WHILE USING ACTIS SIZE 4 BROACH, BROACH WAS BROKEN IN PATIENT'S FEMUR. NO SURGICAL DELAY. ADDITIONAL INFORMATION STATED THAT THE HANDLE WAS DEFECTIVE. EXAMINATION OF THE RETURNED INSTRUMENT BY DEPUY MATERIAL SCIENTIST ON 17 APR 2020 FOUND THAT THE LOCKING FEATURE WAS DEFORMED AND NOT BROKEN AS PREVIOUSLY REPORTED. THE DAMAGE IS CAUSE BY LOCKING HANDLE BEFORE BROACH IS FULLY SEATED. THE COMPLAINT SAMPLE CONSISTED OF (1) 259807550-EXTRA CURVED BROACH HANDLE, LOT RA185A. REVIEW OF AS400 INDICATED THAT THIS DEVICE WAS DISTRIBUTED FOR USE ON 25 NOV 2014. IN A PREVIOUS INVESTIGATION (COM-162923), THE ROOT CAUSE WAS ATTRIBUTED TO USER ERROR. THERE IS A MACHINED NOTCH LOCATED ON THE BROACH GUIDE SHAFT. WHEN THE BROACH IS FULLY SEATED ONTO THE HANDLE, THE HANDLE CAM JAW MOVES INTO THIS NOTCH AND ENGAGES THE BROACH HOLDING IT FIRMLY IN PLACE. IF THE PART IS NOT FULLY SEATED ON THE HANDLE, THE CAM JAW WILL MAKE CONTACT ON THE FULL DIAMETER OF THE BROACH GUIDE SHAFT. THIS PREVENTS THE FULL RANGE OF MOTION OF THE CAM JAW AND LEVER THEREFORE PUTTING EXCESS FORCE ON THE LEAF SPRING WHEN LOCKING THE HANDLE. WITH THE INCREASING OCCURRENCE OF LOWER-VISIBILITY SMALL INCISION CASES, IT IS IMPORTANT TO ENSURE THAT THE ALIGNMENT FEATURES ON BOTH THE HANDLE AND BROACH ARE MATED CORRECTLY, AS PROPER LOCKING WILL EXTEND THE LIFE OF ALL BROACH HANDLES. WITH CORRECT USE, THE LEAF SPRING WILL ONLY FLEX A FEW MILLIMETERS. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. COMPLAINTS WILL BE MONITORED UNDER SEP 419 POST MARKET SURVEILLANCE.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 WHILE USING ACTIS SIZE 4 BROACH, BROACH WAS BROKEN IN PATIENT'S FEMUR. NO SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402999 EXTRA CURVED BROACH HANDLE HIP INSTRUMENTS : HANDLES HTQ DEPUY ORTHOPAEDICS INC US 2598-07-550 RA185A 10603295148531

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR