BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER FOR SYNFIX(TM)-LR

    MDR report key: 4242769 · Received November 11, 2014

    Report

    Report Number
    9612488-2014-10503
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 16, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE HAS BEEN MODIFIED A DEVICE HISTORY REPORT COULD NOT BE PERFORMED AS THE LOT NUMBER PROVIDED, 8081, WAS MODIFIED BY ANOTHER MANUFACTURER/SERVICE /REPAIR PROVIDER. THE REVIEW INDICATED NO NONCONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION FOR THIS ARTICLE. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT NO ANOMALIES WERE DETECTED DURING DEVICE HISTORY RECORD REVIEW. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A MANUFACTURING INVESTIGATION WAS CONDUCTED. THE REPORT INDICATES THAT THE INVESTIGATION OF THE COMPLAINED INSTRUMENTS RESULTS IN FOLLOWING DETAILS. BOTH SCREWDRIVER HAS BEEN MODIFIED IN CASE OF REPLACING THE HANDLE WITH A QUICK COUPLING BY EXCHANGE PARTS FROM THE SHAFT PROXIMAL. IN GENERAL EVERY MODIFICATION ON INSTRUMENTS EXCLUDES THESE AUTOMATICALLY FROM WARRANTY/LIABILITY. FURTHERMORE THE INFORMED LOT NUMBERS (7165 AND 8081) ARE NOT REFERABLE IN OUR SYSTEMS, THEREFORE INVESTIGATION ON DOCUMENTATION FOR MATERIAL AND MANUFACTURING COULD NOT PERFORMED. VISUAL INSPECTION ON BOTH INSTRUMENTS CONFIRMED THAT THE TIPS DISTAL ARE MALFORMED. AFTERWARDS AND WITHOUT ANY FURTHER DETAILS IT IS UNFORTUNATELY NOT POSSIBLE TO DETERMINE THE EXACT CAUSE OF THE DAMAGES. A HIGH MECHANICAL FORCE EXPOSED TO PARAMETERS OUTSIDE APPROVED RANGE LEAD INTO A MATERIAL FATIGUE WITH CAUSED THE MALFORMED TIPS. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE SURGEON DISCOVERED THE SCREWDRIVER ABOUT TO BE USED FOR AN ANTERIOR FUSION WAS BROKEN. IT IS UNKNOWN WHEN THAT HAS OCCURRED. THE SURGEON CONTINUED THE PROCEDURE WITH ANOTHER SIMILAR SCREW DRIVER. TWO BROKEN SCREWDRIVERS WERE RETURNED, IT IS UNKNOWN WHEN OR HOW THE SECONDARY DEVICE BROKE. FIVE MINUTES DELAY IN SURGERY, NO PATIENT HARM. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725556 SCREWDRIVER FOR SYNFIX(TM)-LR SCREWDRIVER HXX SYNTHES BETTLACH 2593195

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR