BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDEWIRE Ø3.2 F/PFNA BLADE

    MDR report key: 6038498 · Received October 18, 2016

    Report

    Report Number
    3009450863-2016-10022
    Event Type
    Injury
    Date Received
    October 18, 2016
    Date of Event
    September 30, 2016
    Report Date
    October 5, 2016
    Manufacturer
    SYNTHES BALSTHAL
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: APRIL 22, 2014. 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. 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 USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6). THE GUIDE WIRE BROKE, FRAGMENTS WERE GENERATED AND WERE RETRIEVED. SUBSEQUENTLY, THERE WAS A SIXTY MINUTE SURGICAL DELAY AS THE SURGEON HAD TO CHANGE THE INTENDED SURGICAL PLAN FROM PFNA TO HIP PROSTHESIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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

    AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: THE GUIDE WIRE IS BROKEN AS DESCRIBED IN THE COMPLAINT DESCRIPTION. THERE ARE NO VISUAL DAMAGES OR FUNCTIONAL ISSUES FOUND ON THE RECEIVED CONCOMITANT PARTS, BLADE AND NAIL. ONLY SLIGHTLY WEAR AND TEAR SIGNS COULD BE OBSERVED. BASED ON THESE FINDINGS, THIS INVESTIGATION WILL BE EXECUTED ON THE BROKEN GUIDE WIRE. THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURE WAS ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. UNFORTUNATELY, WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE. WE FOUND THAT THE LONGER BROKEN PART OF THE GUIDE WIRE RUNS IN A CONE AT THE END. THIS IS AN INDICATION THAT THE GUIDE WIRE WAS CUT OFF BY THE REAMER AND THAT THE WIRE WAS EITHER BENT AFTER THE INSERTION OR THAT TOO HIGH LATERAL STRESS, POSSIBLY BY HIGH SOFT TISSUE PRESSURE, WAS APPLIED DURING REAMING. THE ACTUAL SURGICAL TECHNIQUE GUIDE RECOMMENDS ¿IF THE GUIDE WIRE HAS BEEN BENT TO A GREATER EXTENT, REINSERT IT OR REPLACE IT BY A NEW GUIDE WIRE. OTHERWISE, THE GUIDE WIRE MAY BE ADVANCED THROUGH THE JOINT.¿ THE MEASURABLE DIMENSION OF THE GUIDE WIRE WAS AS FAR AS POSSIBLE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATION. THE SHAFT OUTSIDE DIAMETER WITH TOLERANCE DIMENSION WAS MEASURED WITH THE DIMENSION AND PASSED THEREFORE; THE REQUIRED DIMENSION WAS MANUFACTURED IN A QUANTITY OF (B)(4) PIECES ON APRIL 2014. WE ARE NOT AWARE OF ANY QUALITY PROBLEMS OR FAILURES CAUSED BY A FAULTY PRODUCT ON THE ARTICLE. ALSO WE ARE NOT AWARE OF ANY OTHER COMPLAINT FOR THIS ARTICLE- AND LOT NUMBER COMBINATION. FINALLY WE CONCLUDE THAT NO PRODUCT FAULT COULD BE DETECTED AND THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. THE COMPLAINT IS ADEQUATELY ADDRESSED BY THE RISK ASSESSMENT. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES ON AN EVENT IN FRANCE AS FOLLOWS: IT WAS REPORTED THAT BREAKAGE OF A GUIDE WIRE OCCURRED WHEN PASSING THE DRILL BIT. THE SURGEON HAD TO LAY A HIP PROSTHESIS INSTEAD OF THE PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA). SURGERY WAS PROLONGED BY 60 MINUTES. OCTOBER 2016 EMAIL RECEIVED WITH UPDATE. FRAGMENTS WERE GENERATED BUT ALL WERE REMOVED. SURGERY COMPLETED SUCCESSFULLY. COMPLAINT INVOLVES ONE (1) PART. REPORTED CONCOMITANT DEVICES: PFNA NAIL (PART: 472.390S, LOT: UNKNOWN, QUANTITY: 1). PFNA BLADE ( PART: 04.027.038S, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689783 GUIDEWIRE Ø3.2 F/PFNA BLADE GUIDE FZX SYNTHES BALSTHAL 8952236

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BLADE, 04.027.038S, LOT: UNKNOWN, QUANTITY: 1| NAIL 472.390S, LOT: UNKNOWN, QUANTITY: 1