BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0MM FLEXIBLE SHAFT

    MDR report key: 6070613 · Received November 1, 2016

    Report

    Report Number
    9612488-2016-10440
    Event Type
    Malfunction
    Date Received
    November 1, 2016
    Date of Event
    October 9, 2016
    Report Date
    October 10, 2016
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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: PATIENT WEIGHT IS UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. MANUFACTURING LOCATION: PART 352.040, SYNTHES LOT 5294643, SUPPLIER'S LOT 2201779: (B)(4). MANUFACTURING DATE: JUNE 23, 2006. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (5.0MM FLEXIBLE SHAFT), PART NUMBER 352.040, LOT NUMBER 5294643 THE SUBJECT DEVICES WERE RETURNED WITH THE COMPLAINT CONDITION STATING THAT THE 5.0MM FLEXIBLE SHAFT SHOWS A TWISTED TIP. IN ADDITION THE TIP IS BROKEN WITH FRAGMENTS MISSING. THE REMAINDER OF THE DEVICE SHOWS SURFACE WEAR AND SCRATCHES AND THE RETURNED 14.0MM MEDULLARY REAMER HEAD IS BROKEN. THERE WERE TWO PIECES RETURNED, AND A PORTION OF THE HEAD IS MISSING. A VISUAL INSPECTION, COMPLAINT HISTORY REVIEW, DRAWING REVIEW, DHR REVIEW AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE COMPLAINT IS CONFIRMED. THE 352.040 5.0MM FLEXIBLE SHAFT AND 352.140 14.0MM MEDULLARY REAMER HEAD ARE INSTRUMENTS ROUTINELY USED IN THE FLEXIBLE REAMERS FOR INTRAMEDULLARY NAILS SYSTEM. THE DESIGN HISTORY WAS NOT FOUND TO IMPACT THE COMPLAINT CONDITION. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED. IT IS LIKELY THAT CONSISTENT USE AND POSSIBLY ENCOUNTERING HIGHER RESISTANCE THAN EXPECTED WHILE REAMING HAS LED TO THIS COMPLAINT CONDITION IN THE 5.0MM FLEXIBLE SHAFT AND 14.0MM MEDULLARY REAMER HEAD. 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 A PATIENT UNDERWENT A DISTAL FEMUR FRACTURE (RIGHT SIDE) PROCEDURE ON (B)(6) 2016. DURING THE PROCEDURE, THE SURGEON MEASURED THE CANAL WITH A RULER AND BEGAN TO REAM WITH A 14MM MEDULLARY REAMER HEAD AND 5.0MM FLEXIBLE SHAFT. THE REAMER HEAD BROKE AND THE FLEXIBLE SHAFT BECAME TWISTED AND WAS DAMAGED AS WELL. THERE WERE THREE FRAGMENTS GENERATED WHICH WERE EASILY REMOVED. THERE WAS A SURGICAL TIME DELAY OF TEN (10) MINUTES; THERE WERE BACK-UP DEVICES READILY AVAILABLE. PLANNED X-RAYS WERE TAKEN DURING THE PROCEDURE. THE SURGERY WAS SUCCESSFULLY COMPLETED. THE PATIENT STATUS/OUTCOME IS REPORTED AS GOOD. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721105 5.0MM FLEXIBLE SHAFT REAMER HTO SYNTHES BETTLACH 2201779

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR