BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/100MM

    MDR report key: 6291739 · Received January 31, 2017

    Report

    Report Number
    2520274-2017-10340
    Event Type
    Malfunction
    Date Received
    January 31, 2017
    Report Date
    January 10, 2017
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. BASED ON THE INVESTIGATION, THE UNKNOWN MALLET IS THE ONLY CONCOMITANT DEVICE FOR THIS COMPLAINT. MALLET WAS INITIALLY REPORTED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 20 JANUARY 2015 NO NON-CONFORMANCES 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. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE. THE 03.010.486 LOT NUMBER 9200414 RADIOLUCENT INSERTION HANDLE WAS RETURNED AND REPORTED TO HAVE THE ¿KEY¿ PIECE CHIPPED OFF AND MISSING. THIS COMPLAINT CONDITION WAS LIKELY CAUSED BY OVER TWO YEARS OF CONSISTENT USE AND POSSIBLE ROUGH HANDLING; HOWEVER, THIS COMPLAINT IS NOT LIKELY A RESULT OF ANY DESIGN OR MANUFACTURING RELATED DEFICIENCY. A VISUAL INSPECTION AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THIS COMPLAINT IS CONFIRMED. THE 03.010.486 RADIOLUCENT INSERTION HANDLE AND 03.010.063 12.0MM/8.0MM PROTECTION SLEEVE ARE INSTRUMENTS ROUTINELY USED IN THE 01.013.303 RETROGRADE/ANTEGRADE FEMORAL NAIL-EX INSTRUMENT SET AND THE TITANIUM CANNULATED TIBIAL NAILS SYSTEM (RELEVANT TECHNIQUE GUIDE). THE 03.010.486 INSERTION HANDLE WAS RETURNED AND REPORTED TO HAVE THE ¿KEY¿ PIECE CHIPPED OFF AND MISSING. THIS CONDITION IS CONFIRMED; THE ANTI-ROTATION TANG OF THE HANDLE HAS SHEARED OF AND BEEN WORN DOWN TO ONLY A SMALL BUMP. THE DEVICE WAS MANUFACTURED IN 1/2015 AND IS OVER TWO YEARS OLD. THE BALANCE OF THE RETURNED DEVICE IS IN OTHERWISE FAIR CONDITION WITH ONLY SOME VISIBLE WEAR ALONG ITS LENGTH. DRAWING WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. THE CONDITION OF THE RETURNED DEVICE DOES AGREE WITH THE COMPLAINT DESCRIPTION. WHETHER THE COMPLAINT CONDITION FOR THIS DEVICE CAN BE REPLICATED IS NOT APPLICABLE FOR THIS CONDITION. ALL MEASUREMENTS HAVE BEEN PERFORMED BY CALIPERS. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. 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 USED FOR TREATMENT, NOT DIAGNOSIS NO PATIENT INVOLVEMENT REPORTED. OTHER UDI: (B)(4) LOT NUMBER UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED TO SYNTHES MANUFACTURER FOR EVALUATION /INVESTIGATION, BUT HAS YET TO BE RECEIVED. CONCOMITANT DEVICES REPORTED: AIMING ARM FOR RETROGRADE STANDARD LOCKING (PART # 03.010.050, LOT # UNKNOWN, QUANTITY 1), 12.0MM/8.0MM PROTECTION SLEEVE 188MM (PART # 03.010.063, LOT # UNKNOWN, QUANTITY 1), MALLET (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND 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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED. IT WAS REPORTED THAT THE DEMONSTRATION INVOLVED THE EDUCATION OF THE USE OF ANTEGRADE FEMORAL ASPECT OF THE RAPID RETROGRADE FEMORAL NAIL (R-AFN). THE REPORTER WAS DEMONSTRATING OUT THE DEVICES CAN BE USED, INTERCHANGEABLY, WITH THE GREEN TROCARS FROM BOTH THE TROCHANTERIC FIXATION NAIL SYSTEM OR A TIBIA SET. IN SHOWING THAT THE TROCARS WERE INTERCHANGEABLE, IT WAS NOTED THAT THE INSERTION HANDLE WAS MISSING A COMPONENT; THE "KEY" PIECE THAT IS ON THE DEVICE WAS CHIPPED OFF AND NOTED TO BE MISSING MAKING THE DEVICE ATTACHED (THE PROTECTION SLEEVE AND THE RETROGRADE AIMING ARM GET STUCK TOGETHER. BECAUSE OF THE BROKEN, CHIPPED OFF PIECE THE DEVICES WERE JAMMED TOGETHER AND COULD NOT BE DISCONNECTED. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IN-SERVICE DEMONSTRATION OF DEVICES INCLUDED IN THE TFN-A SET (TROCHANTERIC FIXATION NAIL- ADVANCED) IT WAS NOTED THAT AN INSERTION HANDLE WAS MISSING A COMPONENT; THE "KEY" PIECE THAT IS ON THE DEVICE WAS CHIPPED OFF AND NOTED TO BE MISSING. THE REPORTER STATED THAT DURING THE DEMONSTRATION HE WAS STILL ABLE TO CONNECT THE INSERTION HANDLE TO THE TROCHANTERIC FIXATION NAIL (ADVANCED) AS THERE ARE NO THREADS ON THE INSERTION HANDLE. WHEN HE ATTEMPTED TO CONNECT THE INSERTION HANDLE ONTO THE TROCARS (RETROGRADE AIMING ARM AND THE OUTER PROTECTION SLEEVE), THE DEVICES WENT HALFWAY IN AND THEN GOT STUCK TOGETHER. THE REPORTER ATTEMPTED TO TWIST THE DEVICE TOGETHER PROPERLY, HE THEN TRIED WATER TO SEPARATE AND RE-MATE THEM TO NO AVAIL. IT WS ALSO STATED HE HAD TO USE A MALLET TO FIT THEM TOGETHER PROPERLY, HOWEVER, HE DID NOT TRY TO ATTACHED THE ANTEGRADE AIMING DEVICE NOR THE SPIRAL BLADE WHICH AN ALTERNATIVE DEVICES USED AS SECONDARY OPTION TO INSERT THE NAIL. THE REPORTER STATED THAT THE INNER TROCARS ARE FINE BUT THAT THE RETROGRADE AIMING ARM AND THE OUTER PROTECTION SLEEVE (THE OUTER TROCARS) ARE CONCOMITANT DEVICES. IT WAS CONFIRMED THAT NO OTHER DEVICES WERE USED DURING THE DEMONSTRATION. THIS COMPLAINT INVOLVES ONE (1) DEVICE. CONCOMITANT DEVICES REPORTED: AIMING ARM FOR RETROGRADE STANDARD LOCKING (PART # 03.010.050, LOT # UNKNOWN, QUANTITY 1), 12.0MM/8.0MM PROTECTION SLEEVE 188MM (PART # 03.010.063, LOT # UNKNOWN, QUANTITY 1), MALLET (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71807 RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/100MM MISC ORTHO SURGICAL INSTRUMENT LXH SYNTHES HAGENDORF 9200414

    Patients

    Seq Age Sex Outcome Treatment
    1 03.010.050,| 03.010.063