BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELICAL BLADE INSERTER

    MDR report key: 3819098 · Received May 19, 2014

    Report

    Report Number
    3003787298-2014-10020
    Event Type
    Malfunction
    Date Received
    May 19, 2014
    Report Date
    April 27, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: EVENT DATE: UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS COMPLETED: NO ISSUES WERE FOUND DURING MANUFACTURE THAT WOULD CONTRIBUTE TO THE COMPLAINT 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

    ADDITIONAL NARRATIVE: 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: ONE PART # 357.372 WAS RECEIVED IN GOOD CONDITION. GOLD HANDLE HAS SLIGHT MARKS FROM HAMMER BLOWS; THE SHAFT HAS ROLL MARKS; ALIGNMENT PIN FOR T-HANDLE IS DEFORMED; AND DISTAL BALL BEARINGS HAVE SIGNIFICANT FLATS ON THEM. ONE OF THE FOLLOWING INSTRUMENT(S) WAS RECEIVED WITH A COMPLAINT CATEGORY OF STICKS/JAMS/STUCK: HELICAL BLADE INSERTER (357.372 / LOT # 5120691 / MFG LOCATION: BRANDYWINE / MFG. DATE: 11/2005). THE RELEVANT DRAWING FOR THE INSTRUMENT WAS REVIEWED AND IS DETERMINED TO BE SUITABLE FOR THE DESIGN AND RELATED DIMENSIONAL CONFORMITY. THE HELICAL BLADE INSERTER SHOWS MODERATE USE DURING ITS 10 MONTH LIFESPAN. THE GOLD HANDLE HAS A FEW GOUGES/SCRATCHES AND DENTS FROM HAMMER BLOWS. THE INTERNAL ALIGNMENT PIN FOR THE T-HANDLE IS DEFORMED. THE DISTAL BALL BEARINGS HAVE MINOR FLATS ON THEM. THE RETURNED INSTRUMENT IS PART OF THE TROCHANTERIC FIXATION NAIL SYSTEM (TFN); AND PROPER USE AND MAINTENANCE ARE ADDRESSED IN THE TECHNIQUE GUIDE. THE INSERTER IS USED TO ORIENT AND INSERT HELICAL BLADES TO PROXIMALLY LOCK TFN¿S. THE INTERNAL PIN THAT PREVENTS ROTATION OF THE T-HANDLE IS DEFORMED AND WORN TO THE POINT THAT IT IS DIFFICULT TO REMOVE THE T-HANDLE. THIS DAMAGE AND COMPLAINT CONDITION IS DUE TO INADVERTENT HAMMER BLOWS TO THE HANDLE AND METHOD OF USE, RATHER THAN THE DESIGN OF THE INSTRUMENT. THIS COMPLAINT CONDITION IS A RESULT OF INADVERTENT HAMMER BLOWS, NOT THE DEVICE'S DESIGN. BECAUSE OF THIS, THE COMPLAINT IS DETERMINED NOT TO BE A DESIGN DEFICIENCY. THE RETURNED PART IS DETERMINED TO BE SUITABLE FOR ITS INTENDED USE WHEN USED AND MAINTAINED AS RECOMMENDED. THIS COMPLAINT IS CONFIRMED, AND THE DESIGN OF THE DEVICE DID NOT CONTRIBUTE TO THIS COMPLAINT. MFR DATE: NOV 2005. 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 HELICAL BLADE INSERTER NUT IS STUCK ON THE INSERTER, IT WAS REPORTED THAT THE DEVICE COULD NOT BE PROPERLY CLEANED BECAUSE OF EVENT. THE DEVICE WAS DISCOVERED DURING STERILE PROCESSING. THE EVENT WAS NOT RELATED TO A SPECIFIC PATIENT OR CASE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297481 HELICAL BLADE INSERTER MISC ORTHO SURGICAL INSTR LXH SYNTHES BRANDYWINE 5120691

    Patients

    Seq Age Sex Outcome Treatment
    1