BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFNA Ø10 LONG LE 130° L360 TAN

    MDR report key: 6761963 · Received August 2, 2017

    Report

    Report Number
    9612488-2017-10380
    Event Type
    Injury
    Date Received
    August 2, 2017
    Report Date
    July 21, 2017
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    JDS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED TO MANUFACTURER. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. CONCOMITANT DEVICES: 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

    ADDITIONAL PATIENT IDENTIFIER REPORTED AS (B)(6). DATE OF POSTOPERATIVE NAIL BREAKAGE IS UNKNOWN. A MANUFACTURING INVESTIGATION WAS PERFORMED. THE PRODUCT WAS RETURNED IN A PACKAGING DIFFERENT FROM THE ORIGINAL SYNTHES BAG. THE LASER MARKING WAS READABLE. TRACES OF USE WERE VISIBLE ON NAIL AND THE NAIL IS BROKEN IN THE REGION OF DISTAL DIAMETER 10. AS RELEVANT FOR THE COMPLAINT CONDITION; THE OUTER DIAMETER AND THE INNER DIAMETER OF THE BROKEN NAIL WERE IDENTIFIED AND MEASURED. THE RELEVANT DIMENSIONS WERE MEASURED NEAR THE BROKEN REGION AND THEY HAVE FULFILLED THE SPECIFICATIONS. NO MANUFACTURING ERROR WAS FOUND. THE NAIL WAS MANUFACTURED PER ITS SPECIFICATIONS. BESIDES, DURING THE MANUFACTURING PROCESS THE LOT (9855038) WAS INSPECTED THROUGH THE INSPECTION SHEET AND HAVE MEET ITS SPECIFICATIONS. THE RAW MATERIAL CERTIFICATE WAS CHECKED AND ALL USED RAW MATERIAL USED FULFILLED THE SPECIFICATIONS. BASED ON THE INVESTIGATION THE COMPLAINT IS CONFIRMED SINCE THE NAIL IS BROKEN AS CLAIMED BY THE CUSTOMER. HOWEVER, THIS COMPLAINT IS RATED AS NOT VALID BECAUSE THE RELEVANT DIMENSIONS OF THE NAIL WERE MEASURED AS WELL AS THE RELEVANT MANUFACTURING DOCUMENTATION RELATED TO THE ARTICLE (04.027.227S) WAS REVIEWED AND NO MANUFACTURING ISSUE COULD BE FOUND. 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 PERFORMED. THE EXAMINATION OF THE RAW-MATERIAL TESTING CERTIFICATE AND THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING, DIMENSIONS, MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES OF THE NAIL WERE IN COMPLIANCE WITH AO/ASIF SPECIFICATION AND WITH THE INTERNATIONAL STANDARD ISO 5832-11 FOR TAN (WROUGHT TITANIUM 6-ALUMINIUM 7-NIOBIUM ALLOY). THE FRACTURE FACE OF THE IMPLANT IS HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY. BASED ON THE PROVIDED INFORMATION, WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS BREAKAGE. WE CAN ONLY ASSUME THAT ANY OCCURRENCE DURING THE HEALING PROCESS, E.G. NON-UNION, DELAYED UNION, OVERLOADING OR A COMBINATION OF DIFFERENT FACTORS, DID LEAD TO A FATIGUE FAILURE OF THE NAIL. CONCOMITANT DEVICES: THERE IS NO INDICATION THAT ANY OF THE LISTED CONCOMITANT DEVICE (PFNA BLADE, TWO LOCKING BOLTS) DID CONTRIBUTE ON THIS COMPLAINT CONDITION, ALSO THERE IS NO ALLEGATION AGAINST ONE OF THESE DEVICES. THEREFORE ONLY A VISUAL INSPECTION ON THESE DEVICES WILL BE PERFORMED. THE PFNA BLADE, LOCKING BOLTS SHOWS THAT THE DEVICES ARE IN A USED CONDITION WITHOUT HEAVY DAMAGE. THE SURFACE OF THIS IMPLANTS HAS WEAR MARKS IT IS NOT POSSIBLE TO DETERMINE WHERE IT IS COMING FROM. WE CAN ONLY ASSUME, THAT THIS CAN BE TRACED DURING REMOVAL OR A POSSIBLE INSTABILITY OF THE FRACTURE SITUATION. COMPLAINT IS DISPOSED AS CONFIRMED DUE TO EVIDENCE THAT NAIL IS BROKEN (IN THE REGION OF DISTAL DIAMETER 10MM), BUT IT'S CONSIDERED NOT VALID FOR MANUFACTURING STANDPOINT BECAUSE THERE IS NO EVIDENCE OF ISSUES MANUFACTURING RELATED. 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. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (B)(4). DEVICE IS EXPECTED TO BE RETURNED TO SYNTHES MANUFACTURER FOR EVALUATION /INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). THE 510K# UNKNOWN: DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT: 04.027.227S / 9855038, MANUFACTURING LOCATION: (B)(6), MANUFACTURING DATE: MARCH 11, 2016, EXP DATE: MARCH 01, 2026. 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

    CONCOMITANT DEVICES REPORTED: BLADE (04.027.034S, LOT L127426, QUANTITY 1), LOCKING BOLT (459.340, LOT 5940852, QUANTITY 1), LOCKING BOLT (459.360, LOT 5940131, QUANTITY 1).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT POST-OPERATIVELY THE PROXIMAL FEMORAL NAIL ANTI ROTATE (PFNA) BROKE. THE IMPLANTS WERE INITIALLY IMPLANTED ON (B)(6) 2016 AND REVISED ON (B)(6) 2017. NO INFORMATION AVAILABLE ABOUT PATIENT CONDITION AND OUTCOME. CONCOMITANT REPORTED PARTS: 1X PFNA BLADE (PART 04.027.034S LOT L127426); 2X LOCKING BOLT (PART 459.340 LOT UNKNOWN). THIS COMPLAINT INVOLVES 1 PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540713 PFNA Ø10 LONG LE 130° L360 TAN NAIL, FIXATION, BONE JDS SYNTHES BETTLACH 9855038

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention