BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORQUE LIMITING HANDLE

    MDR report key: 3955065 · Received July 24, 2014

    Report

    Report Number
    1719045-2014-10334
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 27, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JDQ
    PMA / PMN Number
    PK002110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. ADDITIONAL MANUFACTURER DATE: MAY 13, 2004. 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: BEERE PRECISION (PRESENTLY TECOMET KENOSHA) MANUFACTURED THE TORQUE LIMITING HANDLE. THE CERTIFICATE OF COMPLIANCE INDICATES THE LOT WAS MANUFACTURED AND CONFORMED TO SPECIFICATIONS, PER THE RELEVANT SYNTHES DRAWING. THE LOT WAS INSPECTED AND CONFORMED TO THE SYNTHES INSPECTION SHEET. THERE WERE NO COMPLAINT-RELATED ISSUES, MATERIAL REVIEW REPORTS, OR NON-CONFORMANCE REPORTS THAT WOULD CONTRIBUTE TO THE COMPLAINED CONDITION. 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 INVESTIGATION WAS CONDUCTED. THE REPORT INDICATES THAT DUE TO AN UNKNOWN CAUSE, THE CABLE TORQUE LIMITING HANDLE WAS NOT WORKING. THE SURGEON STATED THAT THE TORQUE HANDLE WAS JUST SPINNING FREELY. SUPPLIER STATED THAT UPON RECEIPT, ¿THE COLLAR WAS SPINNING ON THE ADJUSTABLE DIAL¿. INVESTIGATION BY THE SUPPLIER SHOWED THAT ¿UPON RECEIPT OF THE TORQUE INSTRUMENT THE COLLAR WAS SPINNING ON THE ADJUSTABLE DIAL.¿ ¿UPON DISASSEMBLING THE INSTRUMENT THERE WERE NO NON-CONFORMING FEATURES THAT RELATE TO THE COMPLAINT.¿ BASED ON THE EVALUATION AT THE SUPPLIER, THE COMPLAINT CONDITION IS CONFIRMED BUT IS NOT MANUFACTURING-RELATED. 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 (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A SYNTHES SPINE CABLE TORQUE LIMITING HANDLE WAS NOT WORKING A POSTERIOR CERVICAL SPINE FUSION AT A FRACTURED C7; THE SURGEON HAD TO TIGHTEN THE CABLE BY HAND. THE SURGEON DID NOT FEEL THERE WOULD BE ANY IMPLICATIONS FOR THE PATIENT. THE PROCEDURE WAS DELAYED BY ONE MINUTE. THE SURGEON WAS ABLE TO MANUALLY TIGHTEN THE CABLE. THE SURGEON STATED THAT THE TORQUE HANDLE WAS JUST SPINNING FREELY. STATUS OF THE PATIENT POST OPERATIVELY IS UNKNOWN. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434207 TORQUE LIMITING HANDLE CERCLAGE FIXATION JDQ SYNTHES MONUMENT 539189D04

    Patients

    Seq Age Sex Outcome Treatment
    1