BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFNA BLADE PERF L95 TAN

    MDR report key: 8264883 · Received January 21, 2019

    Report

    Report Number
    8030965-2019-60128
    Event Type
    Malfunction
    Date Received
    January 21, 2019
    Date of Event
    January 1, 2019
    Report Date
    January 2, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    UDI-DI
    07611819368989
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. VISUAL INSPECTION: THE RECEIVED INSTRUMENT IS ALL IN ALL IN GOOD CONDITION. THERE ARE JUST SMALL SCRATCHES ON THE SURFACE VISIBLE. FUNCTIONAL TEST: A FUNCTIONAL TEST WAS PERFORMED AND HAS SHOWN THAT THE BLADE IS FUNCTION AS INTENDED. THE BLADE CAN BE LOCKED AND UNLOCKED WITHOUT ANY PROBLEMS. THE COMPLAINT PROBLEM COULD NOT BE REPLICATED THAT AS THE PART IS FULLY FUNCTIONAL. SUMMARY: THE RECEIVED INSTRUMENT IS ALL IN ALL IN GOOD CONDITION. THERE ARE JUST SMALL SCRATCHES ON THE SURFACE VISIBLE. A FUNCTIONAL TEST WAS PERFORMED AND HAS SHOWN THAT THE BLADE IS FULLY FUNCTIONAL. THE COMPLAINED PROBLEM COULD NOT BE REPLICATED. THIS LOT WAS MANUFACTURED IN JULY 2018 ACCORDING TO THE SPECIFICATION. BASED ON THAT AND THE CONDITION OF THE ITEM A PRODUCT RELATED ISSUE CAN BE EXCLUDED. UNFORTUNATELY THE EXACT CAUSE WHICH HAS LED TO THIS COMPLAINT COULD NOT BE EVALUATED AS THE PRODUCT IS FUNCTION AS INTENDED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AS NO PRODUCT RELATED ISSUE COULD BE DETECTED. DEVICE HISTORY LOT: PART: 04.027.034S, LOT: L973060, MANUFACTURING SITE: BETTLACH, RELEASE TO WAREHOUSE DATE: 23.JUL.2018, EXPIRY DATE: 01.JUL.2028. THE DEVICE HISTORY RECORD SHOWS THIS LOT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS 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 IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) PROCEDURE FOR A PROXIMAL FEMORAL FRACTURE ON (B)(6) 2019. DURING THE PROCEDURE, THE SURGEON NOTICED THAT THE PFNA BLADE WAS IN A LOCKED POSITION AND DID OPEN EVEN THOUGH IT WAS PLACED ON AN UNKNOWN INSERTER. THE SURGEON CHANGED TO A NEW SIMILAR BLADE WITH THE SAME SIZE TO SUCCESSFULLY COMPLETE THE PROCEDURE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN INSERTER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1), THIS REPORT IS FOR ONE (1), PFNA BLADE PERF L95 TAN. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57699 PFNA BLADE PERF L95 TAN ROD, FIXATION, INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH L973060 07611819368989

    Patients

    Seq Age Sex Outcome Treatment
    1