BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFNA Ø9 SM 130° L200 TAN

    MDR report key: 6509245 · Received April 20, 2017

    Report

    Report Number
    9612488-2017-10178
    Event Type
    Injury
    Date Received
    April 20, 2017
    Report Date
    March 28, 2017
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: DHR REVIEW WAS COMPLETED. PART NUMBER: 472.431S SYNTHES LOT NUMBER: 9737563 RELEASE TO WAREHOUSE DATE: 08.DEC.2015 EXPIRY DATE: 01.DEC.2025 MANUFACTURING SITE: (B)(4) 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. CUSTOMER QUALITY CONDUCTED AN INVESTIGATION OF THE RETURNED DEVICE. OUR INVESTIGATION HAS SHOWN, THAT WE DID RECEIVE A BROKEN NAIL, A BLADE AND A SCREW BACK. THERE ARE VISIBLE MECHANICAL DAMAGES VISIBLE ON THE NAIL'S SURFACE. FURTHERMORE SIGNS OF USE WERE DETECTED ON THE BLADE AS WELL AS ON THE SCREW. AS THE BLADE AND THE SCREW HAVE NOT CONTRIBUTED TO THE COMPLAINT CONDITION. NO ADDITIONAL INVESTIGATION WILL BE PERFORMED ON THIS DEVICES. WE HAVE FORWARDED THE RECEIVED DEVICES TO THE RESPONSIBLE MANUFACTURING SITE FOR FURTHER EVALUATION WITH THE FOLLOWING RESULTS: THE RELEVANT DIMENSIONS WERE MEASURED AND HAVE FULFILLED THE SPECIFICATIONS. THE DISTAL HOLE, WHERE THE NAIL WAS BROKEN, COULD NOT BE MEASURED. DURING THE MANUFACTURING PROCESS, THE DIAMETERS MEASURED WERE ALSO INSPECTED THROUGH AN INSPECTION SHEET AND HAVE PASSED THEIR SPECIFICATIONS. THEREFORE, NO MANUFACTURING ERROR WAS FOUND. BASED ON THE INVESTIGATION RESULTS, THIS COMPLAINT IS CONFIRMED SINCE THE NAIL IS BROKEN AS CLAIMED BY THE CUSTOMER. FINALLY, WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCE'S. THE DESIGN AND CLINICAL RISK MANAGEMENT (DCRM) DOCUMENT, WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE HARM OF THIS COMPLAINT CONDITION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED 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

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 NARRATIVE: PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. DATE OF DEVICE BREAKAGE IS NOT KNOWN. (B)(4). DATE OF IMPLANT AND DATE OF EXPLANT IS NOT KNOWN. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    THE INITIAL SURGERY WAS PERFORMED DUE TO AN UNDER TROCHANTERIC FRACTURE. CONCOMITANT DEVICE: PFNA BLADE (PART 04.027.034, LOT L145617, QUANTITY 1); LOCKING BOLT (PART 459.360, LOT 5940621, QUANTITY 1).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT IS REPORTED PATIENT WAS IMPLANTED WITH A PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) ON UNKNOWN DATE. THE PFNA IS REPORTED TO HAVE BROKEN THREE (3) MONTHS POST-OPERATIVELY. PATIENT WAS RETURNED TO SURGERY ON UNKNOWN DATE FOR A REVISION. THE HARDWARE PATIENT WAS REVISED TO WAS NOT REPORTED. THIS REPORT IS FOR ONE (1) PFNA. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290353 PFNA Ø9 SM 130° L200 TAN ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES BETTLACH 9737563

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention