BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0MM FLEXIBLE SHAFT

    MDR report key: 6342927 · Received February 20, 2017

    Report

    Report Number
    9612488-2017-10061
    Event Type
    Malfunction
    Date Received
    February 20, 2017
    Report Date
    January 24, 2017
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HTO
    UDI-DI
    10886982194114
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS ADDITIONAL NARRATIVE: A PRODUCT INVESTIGATION WAS PERFORMED. ONE 5.0MM FLEXIBLE SHAFT (PART NUMBER 352.040 / LOT NUMBER 2090792) WAS RECEIVED WITH THE COMPLAINT CATEGORY OF ¿BROKEN: TIP BROKEN PROCEDURAL STEP UNKNOWN.¿ IT WAS REPORTED THAT A 5.0MM FLEXIBLE SHAFT WAS FOUND BROKEN AT THE TIP. IT IS UNKNOWN WHEN THE SHAFT BROKE. IT WAS NOT RECOGNIZED AS BROKEN DURING THE PROCEDURE. THE COMPLAINT CONDITION IS CONFIRMED AS THE FLEXIBLE SHAFT WAS RECEIVED WITH ONE OF THE FOUR DISTAL PRONGS BROKEN OFF. THE TRANSVERSE BREAK IS LOCATED APPROXIMATELY 2.75MM DISTAL TO THE BASE OF THE PRONG. THE BROKEN PORTION WAS NOT RECEIVED. THE BALANCE OF THE DEVICE SHOWS WEAR CONSISTENT WITH SUBSTANTIAL USE OVER THE DEVICES APPROXIMATE LIFESPAN OF 12.75 YEARS. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED AS THE DEVICE WAS FOUND IN THIS CONDITION AFTER STERILE PROCESSING. THUS, THE CIRCUMSTANCES AT THE TIME OF THE ISSUE ARE UNKNOWN. THE TRANSVERSE BREAK OF THE DISTAL PRONG IS CONSISTENT WITH ACCUMULATED EXPOSURE (FATIGUE) AND/OR A SINGLE HIGH FORCE EXPOSURE TO LATERAL FORCE WHICH EXCEEDED THE YIELD STRENGTH. A DEVICE HISTORY RECORD (DHR) REVIEW, VISUAL INSPECTION, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT WEIGHT IS NOT AVAILABLE FOR REPORTING. EVENT DATE: UNKNOWN. IMPLANT AND EXPLANT DATES: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY UNDERGOING INVESTIGATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. MANUFACTURER: SYNTHES (B)(4). DATE OF MANUFACTURE DATE: MAR 31, 2004. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. 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 THE 5.0MM FLEXIBLE SHAFT WAS FOUND BROKEN AT THE TIP. THIS WAS DISCOVERED AT STERILE PROCESSING POST-PROCEDURE (CAPTURED IN COMPLAINT (B)(4)) AND AFTER IT WAS CLEANED. IT IS UNKNOWN WHEN THE SHAFT BROKE. IT WAS NOT RECOGNIZED AS BROKEN DURING THE PROCEDURE. AT THE TIME IT WAS DISCOVERED BROKEN, THERE WAS NO KNOWN PATIENT INVOLVEMENT. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125552 5.0MM FLEXIBLE SHAFT REAMER HTO SYNTHES BETTLACH 2090792 10886982194114

    Patients

    Seq Age Sex Outcome Treatment
    1