BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OC UNIV JOINT TORQUE DRIVER

    MDR report key: 8852213 · Received August 1, 2019

    Report

    Report Number
    1526439-2019-51915
    Event Type
    Malfunction
    Date Received
    August 1, 2019
    Report Date
    July 11, 2019
    Manufacturer
    DEPUY SPINE INC
    Product Code
    HWR
    UDI-DI
    10705034221847
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). UDI: (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. VISUAL EXAMINATION OF THE TORQUE DRIVER DID NOT FEATURE ANY IMMEDIATELY OBSERVABLE DEFECTS. THE DRIVER WAS MECHANICALLY TESTED AND FOUND TO BE OUT OF SPECIFICATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THE OC UNIV JOINT TORQUE DRIVER HAS A POTENTIAL FIELD AGE OF 14 YEAR. IT HAS BEEN LIKELY SUBJECTED TO NUMEROUS AUTOCLAVE CYCLES OVER ITS TIME IN USE. EXTENDED USE OVER TIME CAN CAUSE THE INTERNAL LUBRICANT TO DRY UP AND THE INTERNAL COMPONENTS TO BIND. ALTHOUGH NOT PROVEN, THE MOST PROBABLE ROOT CAUSE FOR THE OVER TORQUEING OF THE DRIVER CAN BE ATTRIBUTED TO LACK OF MAINTENANCE DURING ITS TIME IN USE. AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. 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)(4), UNKNOWN. THE DEVICE IS AVAILABLE FOR EVALUATION. INVESTIGATION WILL BE CONDUCTED. FOLLOW UP WILL BE FILED WITH THE INVESTIGATION RESULTS. 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 AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE MOUNTAINEER OCT SPINAL SYSTEM OC UNIVERSAL JOINT TORQUE DRIVER WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE DRAWING SPECIFICATION IS 2.25-2.75. THE TORQUE TESTED HIGH ¿ 3.213-3.475. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645721 OC UNIV JOINT TORQUE DRIVER DRIVER, PROSTHESIS HWR DEPUY SPINE INC 288314000 GB0405 10705034221847

    Patients

    Seq Age Sex Outcome Treatment
    1