BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFNA-II Ø9 LONG LE 130° L300 TAN

    MDR report key: 6811569 · Received August 22, 2017

    Report

    Report Number
    2520274-2017-12143
    Event Type
    Injury
    Date Received
    August 22, 2017
    Report Date
    August 2, 2017
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    JDS
    PMA / PMN Number
    H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. DATE RETURNED TO MANUFACTURER. 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. DATE OF MANUFACTURE. DHR REQUESTED. SYNTHES MANUFACTURING LOCATION WAS DISCOVERED UPON RECEIPT OF SUBJECT DEVICE. PART & LOT NUMBER REPORTED. BRAND NAME REPORTED. UDI: (B)(4). CONCOMITANT DEVICE: 1X 04.027.053/ LOT L186400 BLADE, LENGTH 90 MM, 1X 473.170/ LOT 234998 CAP, EXTENSION 0 MM, TITANIUM, 1X 459.360V/ LOT 5939920 LOCKING BOLT, 1X 459.360V/ LOT 5940193 LOCKING BOLT. 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 HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 473.032S, LOT# 2791253. MANUFACTURING LOCATION: BETTLACH, MANUFACTURING DATE: OCT 11, 2011, EXPIRY DATE: OCT 01, 2021. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE MATERIAL CERTIFICATE WHICH RELATED TO THE PRODUCT (473.032S / LOT 2791253) STATES THAT THE MATERIAL HAS FULFILLED ITS SPECIFICATIONS ACCORDING TO THE RESULTS OBTAINED ON 05/06/2011. MANUFACTURING EVALUATION WAS COMPLETED. 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 THE DISTAL DIAMETER 9. THE DIMENSIONS WERE CHECKED WITH THE DRAWING. THE RELEVANT DIMENSIONS WERE MEASURED NEAR THE BROKEN REGION AND THEY HAVE FULFILLED THE SPECIFICATIONS. THE CROSS-HOLE, WHERE THE NAIL WAS BROKEN, COULD NOT BE MEASURED. DURING MANUFACTURING THE DIMENSION OF THE HOLE WAS CHECKED WITH A GO/NO GO GAGE AND THE SYMMETRY WAS CHECKED WITH A SPECIAL-MICROMETER. NO MANUFACTURING ERROR FOUND. PRODUCT WAS MANUFACTURED ACCORDING TO ITS SPECIFICATIONS. THE RAW MATERIAL CERTIFICATES WERE CHECKED AND THE USED RAW MATERIAL HAS FULFILLED THE SPECIFICATIONS. BESIDES, DURING THE MANUFACTURING PROCESS THE LOT (2791253) WAS INSPECTED AND HAVE MEET ITS SPECIFICATIONS. BASED ON THE INVESTIGATION RESULTS, THIS COMPLAINT IS CONFIRMED SINCE THE NAIL WAS 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 (473.032S) WAS REVIEWED AND NO MANUFACTURING ISSUE COULD BE FOUND. THE NAIL BREAKAGE COULD HAVE BEEN CAUSED TROUGH AN OVERLOADING SITUATION. EXACT ROOT CAUSE COULD NOT BE DETERMINED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. 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. PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. THIS REPORT IS FOR UNKNOWN NAIL FEMORAL PROXIMAL/UNKNOWN LOT NUMBER. OTHER UDI: UNKNOWN, UNKNOWN, UDI UNAVAILABLE. IT WAS REPORTED THAT THE PFNA LONG 9MM WAS USED IN THE PATIENT IN THE SURGERY FOR THE FEMORAL SUBTROCHANTERIC FRACTURE AROUND (B)(6) 2017. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 510K#: UNKNOWN. (B)(4). 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

    DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PFNA LONG 9MM IN QUESTION WAS USED FOR THE PATIENT IN THE SURGERY FOR THE FEMORAL SUBTROCHANTERIC FRACTURE AROUND (B)(6) 2017. ABOUT 10 DAYS AGO, THE NAIL IN QUESTION WAS BROKEN AT THE PROXIMAL LATERAL SIDE OF THE TWO DISTAL LOCKING, AND THE SAME PART OF THE FEMUR WAS ALSO BROKEN. THE SUBTROCHANTERIC FRACTURE PART HAD BEEN ALMOST HEALED. ACCORDING TO THE SURGEON¿S OPINION, THE CAUSE WAS THOUGHT THAT THE MEDULLARY CAVITY OCCUPANCY WAS SMALL BECAUSE THE DIAMETER OF THE NAIL IN QUESTION WAS 9MM; THEREFORE, THE WIPER MOTION OF THE NAIL IN QUESTION EVOKED. THE REPLACEMENT SURGERY (THE NAIL IN QUESTION WAS REMOVED AND REPLACED WITH A TFNA LONG) WAS PERFORMED ON (B)(6) 2017. THIS COMPLAINT INVOLVES 1 PART. CONCOMITANT DEVICE: 1X UNK LOCKING BOLT, 1X UNK HELICAL BLADE, 1X UNK DISTAL SCRE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592503 PFNA-II Ø9 LONG LE 130° L300 TAN NAIL,FIXATION,BONE JDS SYNTHES BETTLACH 2791253

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention