BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS

    MDR report key: 4357972 · Received December 23, 2014

    Report

    Report Number
    2530088-2014-10453
    Event Type
    Malfunction
    Date Received
    December 23, 2014
    Date of Event
    November 25, 2014
    Report Date
    November 25, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    FZX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE DHR WAS REVIEWED AND MRR #(B)(4)WAS FOUND ON P/N 357.366. LOT #5505926 FOR FEATURE D2 OVERSIZE ON 1 OUT OF (B)(4) PARTS. THE MANUFACTURING ENGINEER ACCEPTED THE PARTS AS CONFORMS BECAUSE D2 IS 5 MICRONS OVER THE PRE-ANODIZE MACHINING TOLERANCE OF 11.080/11.060MM. THIS DIFFERENCE OF 5 MICRONS WILL NOT AFFECT THE ANODIZE PROCESS. PARTS ARE INSPECTED 100% AFTER ANODIZE. THIS NONCONFORMANCE IS NOT RELEVANT TO THE COMPLAINT BECAUSE FEATURE D2 DOES NOT INTERFACE WITH THE BLADE GUIDE SLEEVE. MRR #(B)(4)WAS FOUND ON P/N 357.366.1 LOT #5489503 FOR 1.) D2 GO WILL NOT GO ON 1 OUT OF 61 PARTS, 2.) SCRATCH IN ANODIZE ON 1 OUT OF 61 PARTS AND 3.) DIRT AND OIL IN T1 THREADED HOLE ON (B)(4) OUT OF (B)(4) SUPPLIER PARTS. THE NONCONFORMING PARTS IN ITEMS 1 AND 3 WERE REWORKED, INSPECTED 100% AND PASSED. THE 1 NONCONFORMING PART IN ITEM 2 WAS FOUND CONFORMING BECAUSE THE PART MEETS VISUAL REQUIREMENT. THIS NONCONFORMANCE IS NOT RELEVANT TO THE COMPLAINT CONDITION BECAUSE THE ISSUES ARE VISUAL AND D2 DOES NOT INTERFACE WITH THE BLADE GUIDE SLEEVE. MRR #(B)(4) WAS FOUND ON RAW MATERIAL P/N 11051 LOT #5052338 FOR CERT DOES NOT HAVE CHEMICAL COMPOUND (B)(4) ON SUPPLIER MATERIAL. THE SUPPLIER PROVIDED THE CORRECTED CERT AND THE MATERIAL WAS ACCEPTED. THIS NONCONFORMANCE IS NOT RELEVANT TO THE COMPLAINT CONDITION BECAUSE THE ISSUE IS DOCUMENTATION. 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

    A PRODUCT EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT THE RETURNED AIMING ARM WAS RECEIVED INTACT. THE SURFACES THAT INTERACT WITH THE MATING COMPONENTS ARE WORN FROM TYPICAL USE. THE RETURNED AIMING ARM WAS ASSEMBLED WITH THE RETURNED BLADE GUIDE SLEEVE AND BUTTRESS/COMPRESSION NUT. THE ASSEMBLY DID NOT HAVE ANY ISSUES WITH STICKING OR INTERFERENCE. THE MANUFACTURE DATE IS JULY 18, 2007. THE LEGACY - TROCHANTERIC FIXATION NAIL DESIGN AND CLINICAL RISK MANAGEMENT DOCUMENT ((B)(4)) ADEQUATELY ADDRESSES THE COMPLAINT CONDITION ¿DEVICE INTERACTION: STICKS/JAMS/STUCK¿. SPECIFICALLY, LINE# 1190 ASSESS THE FUNCTION ¿AIMING ARMS (357.365, 357.366, 357.367) ATTACHES TO INSERTION HANDLE AND PROVIDES THE INTERFACE FOR BUTTRESS/COMPRESSION NUT, TARGETING SLEEVES AND INSTRUMENTS¿, WITH A HAZARD OF ¿AIMING ARM DOES NOT HOLD/STUCK WITH BUTTRESS/COMPRESSION NUT AND/OR BLADE GUIDE SLEEVE¿ AS ACCEPTABLE RISK WITH A MODERATE SEVERITY OF HARM, THREE, AND AN UNLIKELY PROBABILITY OF OCCURRENCE, TWO, WITH POSSIBLE HARM LISTED AS "SURGICAL DELAY - MODERATE¿. THE ASSEMBLED INSTRUMENTS FUNCTIONED AS INTENDED. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. THE COMPLAINT IS UNCONFIRMED. 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 DURING A PROXIMAL FEMUR FRACTURE PROCEDURE ON (B)(6) 2014 A HELICAL BLADE GUIDE SLEEVE GOT STUCK IN A 130 DEGREE AIMING ARM WHEN AN ATTEMPT WAS MADE TO REPOSITION A GUIDE WIRE. THIS SAME SCENARIO OCCURRED A SECOND TIME DURING THE PROCEDURE WHEN ANOTHER TROCHANTERIC FIXATION NAIL (TFN) LOCKING SET WAS OPENED. IT WAS REPORTED THAT THE 130 DEGREE AIMING ARM LOOKED AS IF IT WAS WORN DOWN OR THREADS DAMAGED ON THE FLAT SIDE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NO PATIENT HARM AND A SURGICAL DELAY OF APPROXIMATELY 2-5 MINUTES. THIS IS REPORT 1 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846329 130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS GUIDE FZX SYNTHES BRANDYWINE 5553143

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR