BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORQUE LIMITING HANDLE 80IN-LB

    MDR report key: 10058344 · Received May 14, 2020

    Report

    Report Number
    1526439-2020-01034
    Event Type
    Malfunction
    Date Received
    May 14, 2020
    Report Date
    May 1, 2020
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    LXH
    UDI-DI
    10705034467399
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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. H10 ADDITIONAL NARRATIVE: H3, H6: INVESTIGATION SUMMARY. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. DEVICE HISTORY LOT. PART NUMBER: 299704320. LOT NUMBER: EX5VDB-210. DEVICE HISTORY REVIEW. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) COULD NOT BE PERFORMED AS NO MANUFACTURING RECORDS COULD BE FOUND FOR THIS PART # 299704320/LOT # EX5VDB-210 COMBINATION. IF FURTHER INFORMATION BECOMES AVAILABLE, THIS DHR CAN BE REVISITED. 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

    ADDITIONAL NARRATIVE: REPORTER IS COMPANY REPRESENTATIVE. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; 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, THE TORQUE WRENCH WAS TESTED AT 89 LBF. INC. THE MAX ALLOWANCE IS 88. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519734 TORQUE LIMITING HANDLE 80IN-LB MISC ORTHO SURGICAL INSTR LXH MEDOS INTERNATIONAL SàRL CH 299704320 EX5VDB-210 10705034467399

    Patients

    Seq Age Sex Outcome Treatment
    1 TORQUE LIMITING HANDLE 80IN-LB