BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIPER PRIME TORQUE HANDLE

    MDR report key: 9406537 · Received December 3, 2019

    Report

    Report Number
    1526439-2019-52549
    Event Type
    Malfunction
    Date Received
    December 3, 2019
    Report Date
    November 7, 2019
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    LXH
    UDI-DI
    10705034507750
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). UDI: (01)10705034507750 (11)190129 (10)GB116809. 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. THERE WAS NO VISUAL DEFECTS TO NOTE WITH THE RETURNED HANDLE. THE DEVICE WAS FUNCTIONALLY 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. A ROOT CAUSE COULD NOT BE DETERMINED, BUT IT IS LIKELY THE DEVICE WAS NOT PROPERLY MAINTAINED AND HAS AN INTERNAL MECHANICAL FAILURE. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. THEREFORE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTIVE ACTION IS PROPOSED.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN REQUESTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE TORQUE HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1197981 VIPER PRIME TORQUE HANDLE SURGICAL INSTRUMENT TORQUE-LIMITING HANDLE LXH MEDOS INTERNATIONAL SàRL CH 286750100 GB116809 10705034507750

    Patients

    Seq Age Sex Outcome Treatment
    1