BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12.0MM/8.0MM PROTECTION SLEEVE188MM

    MDR report key: 5761612 · Received June 30, 2016

    Report

    Report Number
    2520274-2016-13330
    Event Type
    Malfunction
    Date Received
    June 30, 2016
    Date of Event
    June 17, 2016
    Report Date
    June 17, 2016
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT METRIC HEIGHT: (B)(6), BMI: 0.3.; ADDITIONAL CODE: FSM; (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    (B)(6). MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: DECEMBER 21, 2005. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE REVIEW OF THE DEVICE HISTORY RECORD SHOWS THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. 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

    A PRODUCT INVESTIGATION WAS COMPLETED: ONE (1) 12.0/8.0 PROTECTION SLEEVE LENGTH 188MM (PART 03.010.063, LOT 1426039, MANUFACTURED DECEMBER 21, 2005) AND ONE (1) INSERTION HANDLE FOR EXPERT ADOLESCENT LATERAL FEMORAL NAIL (PART 03.010.226, LOT 1690889, MANUFACTURED JUNE 12, 2007) WERE RETURNED WITH A COMPLAINT STATING THAT THE PROTECTION SLEEVE WOULD NOT PASS THROUGH THE ANTEGRADE HOLE OF THE INSERTION HANDLE. A VISUAL INSPECTION, DEVICE HISTORY REVIEW (DHR), COMPLAINT HISTORY REVIEW, DRAWING REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE COMPLAINT WAS ABLE TO BE CONFIRMED AT CUSTOMER QUALITY AS THE DIAMETER OF THE RETROGRADE HOLE FOR THE INSERTION HANDLE WAS MEASURED TO BE FAR BELOW SPECIFICATION. HAMMER MARKS COULD BE FOUND ALONG THE DISTAL HOLE OF BOTH THE RETROGRADE LOCKING HOLE OF THE INSERTION HANDLE AND THE PROTECTION SLEEVE. THE PROTECTION SLEEVE WAS ALSO MEASURED TO HAVE AN UNDERSIZED DISTAL INNER DIAMETER. ALTHOUGH THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, IT IS LIKELY THAT THE DAMAGE OCCURRED AS THE USER ATTEMPTED TO DISENGAGE THE INSTRUMENTS WITH A HAMMER. IT WAS ALSO REPORTED THAT THE PROTECTION SLEEVE HAD DIFFICULTY PASSING THOUGH THE TRANSVERSE HOLE. THE TRANSVERSE LOCKING OPTION IS ACHIEVED WITH THE USE OF AN AIMING ARM. AS AN AIMING ARM WAS NOT RETURNED WITH THE COMPLAINT, THIS PORTION OF THE COMPLAINT DESCRIPTION CANNOT BE CONFIRMED AT THIS TIME. PER THE TECHNIQUE GUIDE, THE 03.010.063 PROTECTION SLEEVE IS ROUTINELY USED DURING THE INSERTION OF VARIOUS FEMORAL AND TIBIAL NAILS IN THE EXPERT NAILING SYSTEMS WHEREAS THE 03.010.226 INSERTION HANDLE IS SPECIFIC TO THE ADOLESCENT FEMORAL NAIL. RELEVANT PRODUCT DRAWINGS WERE REVIEWED DURING THE INVESTIGATION. THE PROTECTION SLEEVE CONFORMED TO THE MAXIMUM OUTER DIAMETER (OD) AT 11.97MM BUT THE MAXIMUM INNER DIAMETER (ID) MEASURED 7.86MM. THE INSERTION HANDLE¿S RETROGRADE HOLE MEASURED A MAX ID OF 11.93MM. HAMMER MARKS COULD BE FOUND ALONG THE DISTAL HOLE OF BOTH THE RETROGRADE LOCKING HOLE OF THE INSERTION HANDLE AND THE PROTECTION SLEEVE THUS IT IS UNLIKELY THAT THE CAUSE OF THE ISSUE IS MANUFACTURING RELATED. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. ALTHOUGH THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, IT IS LIKELY THAT THE DAMAGE OCCURRED AS THE USER ATTEMPTED TO DISENGAGE THE INSTRUMENTS WITH A HAMMER. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE WHEN USED AND MAINTAINED AS RECOMMENDED, IT DID NOT CONTRIBUTE TO THE COMPLAINT CONDITION. PATIENT HEIGHT AND BMI UNKNOWN. 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 ON (B)(6) 2016 THE SURGEON WAS ATTEMPTING TO INSERT AN INTER-MEDULLARY NAIL INTO THE FEMUR; THE INSERTION HANDLE FOR THE ADOLESCENT LATERAL ENTRY FEMORAL NAIL-EX WOULD NOT ACCOMMODATE THE 12.0 MM / 8.0 MM AND THE PROTECTION SLEEVE 188 MM WOULD NOT PASS THROUGH THE ANTEGRADE HOLE. THE SURGEON HAD TO USE THE TRANSVERSE HOLE TO COMPLETE THE PROCEDURE BUT THERE WAS DIFFICULTLY GETTING THE PROTECTIVE SLEEVE TO PASS THROUGH. DUE TO THIS INCIDENT THERE WAS A THIRTY (30) MINUTE DELAY IN THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT'S OUTCOME IS GOOD. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417805 12.0MM/8.0MM PROTECTION SLEEVE188MM MISC ORTHO SURGICAL INSTRUMENT LXH SYNTHES HAGENDORF 1426039

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR