BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFNA-II Ø10 LONG LE 125° L260 TAN

    MDR report key: 6419829 · Received March 21, 2017

    Report

    Report Number
    9612488-2017-10126
    Event Type
    Injury
    Date Received
    March 21, 2017
    Report Date
    February 23, 2017
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    JDS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A MANUFACTURING INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (PFNA-II Ø10 LONG LE 125° L260 TAN, PART NUMBER 473.050S, LOT NUMBER 7967403). THE SUBJECT DEVICE WAS RETURNED TO THE MANUFACTURER WITH THE COMPLAINT CONDITION STATING: AS RECEIVED CONDITION OF DEVICE: THE LASER MARKING WAS READABLE. STRONG TRACES AROUND THE PROXIMAL DIAMETER AND THE CONE OF THE SHAFT. NAIL IS BROKEN ON THE POSITION OF THE DISTAL DIAMETER JUST AFTER THE CONE. ALL DIMENSIONS RELEVANT FOR THE FUNCTION OF THE PRODUCT WERE MEASURED, AND FULFILL THE SPECIFICATIONS. THE RAW MATERIAL CERTIFICATE WAS CHECKED AND IT WAS FOUND THAT THE USED RAW MATERIAL FULFILLED THE SPECIFICATIONS. BASED ON THIS THE COMPLAINT IS CONFIRMED BUT NOT VALID FROM THE POINT OF VIEW OF THE MANUFACTURING SITE. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED, THEREFORE REVIEW TO THE SPECIFIC PRM AND PRM LINE IS NOT APPLICABLE. POSSIBLE ROOT CAUSE FOR THIS COMPLAINT WE REASONABLY CONCLUDE WAS AN OVERLOADING SITUATION WHICH LED TO THIS NAIL BREAKAGE. 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)(4). CONCOMITANT REPORTED PARTS: 1X PFNA-II BLADE (PART 04.027.051S, LOT 9507444). 1X PFNA-II END CAP (PART 473.170S, LOT 9844892). 1X LOCKING BOLT Ø 4.9MM (PART 459.340VS, LOT 5937350). 1X LOCKING BOLT Ø 4.9MM (PART 459.360VS, LOT 5937588). (B)(4). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. A 510K UNKNOWN. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DHR REVIEW WAS PERFORMED: PART #473.050S / LOT #7967403. MANUFACTURING LOCATION: (B)(6). MANUFACTURING DATE: 06.JUL.2012, EXPIRY DATE: 01.JUL.2022. 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6). IT WAS REPORTED THAT THE REPORTED DEVICE HAS BEEN USED IN SURGERY FOR FEMUR SUBTROCHANTERIC FRACTURES ON (B)(6) 2016. A PFNA (PROXIMAL FEMORAL NAIL ANTIROTATION) NAIL HAS BEEN IMPLANTED. HOWEVER, THE SURGEON FOUND THE NAIL WAS BROKEN JUST AROUND THE FRACTURE PART. BESIDES THE PATIENT IS SUFFERING FROM REFRACTURE. SURGICAL REVISION TO REPLACE IT WITH EITHER DIFFERENT SIZED TFNA LONG NAIL OR PFNA LONG NAIL IS PLANNED ON (B)(6) 2017. THIS COMPLAINT INVOLVES 1 PART. THE PATIENT IS CURRENTLY HOSPITALIZED. (B)(4). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204740 PFNA-II Ø10 LONG LE 125° L260 TAN NAIL, FIXATION, BONE JDS SYNTHES BETTLACH 7967403

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 1X PFNA-II BLADE 04.027.051S, 9507444| 1X PFNA-II END CAP PART 473.170S, 9844892