BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIMING ARM FOR ADOLESCENT LATERAL ENTRY FEMORAL NAIL-EX

    MDR report key: 5814302 · Received July 21, 2016

    Report

    Report Number
    3003875359-2016-10424
    Event Type
    Malfunction
    Date Received
    July 21, 2016
    Date of Event
    June 27, 2016
    Report Date
    June 30, 2016
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT HEIGHT IS 5 FEET. THE DEVICE IS CURRENTLY IN THE EVALUATION PROCESS. 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

    PRODUCT INVESTIGATION SUMMARY: ONE (1) ALFN AIMING ARM (PART 03.010.227 / LOT 1962611) WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION, DEVICE HISTORY RECORD REVIEW (DHR), AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE AIMING ARM WAS RECONSTRUCTED WITH THE RETURNED CONCOMITANT INSERTION HANDLE (PART 03.010.226 / LOT 1777480), A KNOWN GOOD PROTECTION SLEEVE (PART 03.010.063 / LOT 3287122), AND A DRILL SLEEVE (PART 03.010.064 / LOT 4939290) IN AN ATTEMPT TO RECREATE THE COMPLAINT CONDITION. HOWEVER, THE COMPLAINT CONDITION COULD NOT BE RECREATED. ALIGNMENT OF THE AIMING ARM WITH THE INSERTION HANDLE WAS ACHIEVED. DURING THE SUBJECT PROCEDURE, HOWEVER, OTHER VARIABLES COULD HAVE CONTRIBUTED TO THE DRILL BIT NOT GOING INTO THE NAIL. SINCE ONLY THE AIMING ARM AND THE INSERTION HANDLE WERE RETURNED, IT IS NOT POSSIBLE TO DETERMINE IF THE OTHER PARTS THAT INTERACTED WITH BOTH DEVICES DURING THE EVENT CONTRIBUTED TO THE DRILL BIT MISALIGNING WITH THE NAIL. ADDITIONALLY, OTHER FACTORS, SUCH AS THE PATIENT¿S CONDITION AND PHYSICAL ATTRIBUTES, COULD HAVE IMPACTED THE POSITIONING OF THE INSTRUMENTATION USED TO FACILITATE LOCKING. PLEASE NOTE: THE FOLLOWING PARTS WERE RETURNED AS CONCOMITANT/UNRELATED DEVICES WITHOUT AN ALLEGED COMPLAINT CONDITION. UPON INSPECTION, THERE WAS NO EVIDENCE THAT ANY OF THESE DEVICES CONTRIBUTED TO THE COMPLAINT CONDITION; THEREFORE, NO ADDITIONAL INVESTIGATION WILL BE PERFORMED ON THESE DEVICES: PART 03.010.226 LOT 1777480; PART 03.010.063 LOT 3287122; PART 03.010.045 LOT 9102679; PART 03.010.048 LOT 9637369; AND PART 03.010.064 LOT 4939290. THE RETURNED AIMING ARM IS PART OF THE EXPERT ADOLESCENT LATERAL FEMORAL NAIL (ALFN) SYSTEM. THE DEVICE AIDS IN THE INSERTION OF THE ALFN DURING FEMORAL SHAFT, SUBTROCHANTERIC, AND IPSILATERAL NECK/NECK FRACTURES. THE RELEVANT DRAWINGS FOR THE RETURNED INSTRUMENTS WERE REVIEWED: TOP-LEVEL. THE DESIGN, MATERIALS, AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USES OF THESE DEVICES. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE RETURNED INSTRUMENTS¿ LOT NUMBERS WITH NO MATERIAL RECORD REPORTS, NON-CONFORMANCE REPORTS, OR COMPLAINT-RELATED ISSUES IDENTIFIED. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. DUE TO THE TIGHT TOLERANCES AND DESIGN, THE CONSTRUCT IS SUSCEPTIBLE TO LATERAL FORCES DURING PROCEDURES THAT ARE UNABLE TO BE REPLICATED AT CUSTOMER QUALITY. FOR EXAMPLE, IT IS LIKELY THAT SOFT TISSUE DISTRACTION FORCES CAUSED THIS COMPLAINT CONDITION. THE ALFN TECHNIQUE GUIDE CAUTIONS AGAINST EXERTING FORCES ON THE AIMING ARM, PROTECTION SLEEVE, DRILL SLEEVES, OR DILL BITS DURING USE AS FORCE MAY PREVENT ACCURATE TARGETING THROUGH THE PROXIMAL LOCKING HOLES. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. DEVICE 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. 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. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 22.OCT.2008, PART 03.010.227 LOT 1962611. NO NCRS 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. 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 DURING STANDARD PROXIMAL LOCKING OF A LEFT, TITANIUM ADOLESCENT LATERAL ENTRY FEMORAL NAIL FOR TREATMENT OF A FEMORAL FRACTURE, THE AIMING ARM WAS NOT ALIGNED CORRECTLY, CAUSING MISALIGNMENT OF THE DRILL BIT WITH THE NAIL. THE SURGEON REMOVED THE DRILL SLEEVE AND USED THE PROTECTION SLEEVE FOR PROPER ALIGNMENT. SURGERY WAS DELAYED A FEW MINUTES. THE REMAINDER OF THE PROCEDURE WAS UNEVENTFUL AND SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS REPORTED AS STABLE. THIS COMPLAINT INVOLVES TWO DEVICES. CONCOMITANT DEVICES: Ø9MM TITANIUM ADOLESCENT LATERAL ENTRY FEMORAL NAIL-EX/340MM/LT/STERILE (PART # 04.031.955S, LOT# 9980298, QUANTITY:1); CONNECTING SCREW (PART# UNKNOWN, LOT # UNKNOWN, QUANTITY: 1); INSERTION HANDLE FOR ADOLESCENT LATERAL ENTRY FEMORAL NAIL-EX (PART# 03.010.226, LOT # 1777480, QUANTITY: 1); 8.0MM/3.2MM DRILL SLEEVE 200MM (PART# 03.010.064 , LOT # UNKNOWN, QUANTITY: 1); 12.0MM/8.0MM PROTECTION SLEEVE (PART# 03.010.063, LOT # UNKNOWN, QUANTITY: 1). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465799 AIMING ARM FOR ADOLESCENT LATERAL ENTRY FEMORAL NAIL-EX GUIDE FZX SYNTHES HAGENDORF 1962611

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR