BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK

    MDR report key: 3080392 · Received April 26, 2013

    Report

    Report Number
    8030965-2013-10993
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Report Date
    November 10, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. THE DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. METHOD: VISUAL INSPECTION, MANUFACTURING RECORD REVIEW, COMPLAINT HISTORY ANALYSIS AND RISK ASSESSMENT. RESULTS - VISUAL INSPECTION - THE DEVICE SHOWS EVIDENCE OF USE SUCH AS MINOR SCRATCHES, DINGS AND DENTS. THE DEVICE IS MISSING THE SET SCREW AS THE COMPLAINT STATES. MANUFACTURING RECORD REVIEW - A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. COMPLAINT HISTORY ANALYSIS - NO PREVIOUS RECORDS FOR THIS PART NUMBER ASSOCIATED WITH THIS ISSUE. THIS DEVICE WAS MANUFACTURED IN OCTOBER 2005 AND WAS IN USE FOR MORE THAN SIX YEARS WITH NO KNOWN ISSUES. IT IS POSSIBLE THAT THE DEVICE WAS TAKEN APART TO STERILIZE AND THE SET SCREW WAS LOST AT THAT TIME. RISK ASSESSMENT - NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES WERE REPORTED. CONCLUSION: WHILE IT IS POSSIBLE THAT THE SCREW WAS LOST DURING THE CLEANING PROCESS, THERE IS NO OBJECTIVE EVIDENCE TO SUPPORT THIS AND IT CAN NOT BE FULLY DETERMINED WHY THE SET SCREW BECAME LOOSE, THEREFORE, THE COMPLAINT IS INDETERMINATE AND THE COMPLAINT CONDITION WAS DUE TO AN UNKNOWN CAUSE.

    Additional Manufacturer Narrative · 1

    DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SALES CONSULTANT NOTICED THAT THE CAP THAT HAS THE SCREW IN IT IS LOOSE AND THE SCREW IS MISSING ON A FLEXIBLE SHAFT CONNECTOR. NO PATIENT INVOLVEMENT AND NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182656 FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK HTO SYNTHES GMBH 2162031

    Patients

    Seq Age Sex Outcome Treatment
    1