BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFNA BLADE PERF L105 TAN

    MDR report key: 7660206 · Received July 3, 2018

    Report

    Report Number
    8030965-2018-54799
    Event Type
    Malfunction
    Date Received
    July 3, 2018
    Date of Event
    June 10, 2018
    Report Date
    June 11, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    UDI-DI
    07611819369504
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR PART: 04.027.036S, LOT: L893128: MANUFACTURING SITE: BETTLACH, RELEASE TO WAREHOUSE DATE: 22.MAY.2018, EXPIRY DATE: 01.MAY.2028: THE DEVICE HISTORY RECORD SHOWS THIS LOT OF (B)(4) PIECES 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. A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE RECEIVED INSTRUMENT IS ALL IN ALL IN GOOD CONDITION. THERE ARE JUST SMALL SCRATCHES ON THE SURFACE VISIBLE. IT WAS FOUND THAT THE LOCKING SCREW IS TOO MUCH INSIDE THE BLADE AND THEREFORE THE BLADE COULD NOT BE LOCKED ANYMORE. FUNCTIONAL TEST: AFTER UNSCREWING THE LOCKING SCREW OUT OF THE BLADE 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. SUMMARY: THE RECEIVED INSTRUMENT IS ALL IN ALL IN GOOD CONDITION. THERE ARE JUST SMALL SCRATCHES ON THE SURFACE VISIBLE. IT WAS FOUND THAT THE LOCKING SCREW IS TOO MUCH INSIDE THE BLADE AND THEREFORE THE BLADE COULD NOT BE LOCKED ANYMORE. THIS COULD HAPPEN, WHEN THE IMPACTOR INSTRUMENT IS NOT ATTACHED CORRECTLY TO THE PFNA BLADE AND WILL BE SCREWED INTO THE BLADE WITHOUT CONTACT WITH THE THREAD. A FUNCTIONAL TEST WAS PERFORMED AND HAS SHOWN THAT THE BLADE IS FULLY FUNCTIONAL. THIS LOT OF (B)(4) PIECES WAS MANUFACTURED IN MAY 2018 ACCORDING TO THE SPECIFICATION. BASED ON THAT A PRODUCT RELATED ISSUE CAN BE EXCLUDED. THE EXACT CAUSE WHICH HAS LED TO THIS COMPLAINT COULD NOT BE EVALUATED. AS THE PART IS FUNCTIONAL AS INTENDED WE DETERMINE THE REPORTED PROBLEM AS HANDLING ERROR. AS THE PRODUCT IS FULLY FUNCTIONAL THE COMPLAINT IN UNCONFIRMED. 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 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 MALFUNCTIONED INTRA-OPERATIVELY AND WAS NOT IMPLANTED / EXPLANTED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) BLADE WAS USED FOR AN UNKNOWN SURGERY ON (B)(6) 2018. WHEN THE SURGEON LOCKED THE BLADE, THE IMPACTOR WAS UNLOCKED FROM THE BLADE, BUT THE SURGEON COULD SEE ON X-RAY THAT THE BLADE HAS NOT BEEN CLOSED IN THE GAP AS IT SHOULD HAVE. THE SURGEON REMOVED THE BLADE, AND REPLACED IT WITH A NEW PFNA BLADE. THERE WAS NO PROBLEM UNPACKING THE ORIGINAL BLADE, MOUNTING IT ON TO THE INSERTER, OR IMPACTING IT IN THE FEMORAL HEAD. SURGERY WAS SUCCESSFULLY COMPLETED. THERE WERE NO REPORTED PATIENT CONSEQUENCES. CONCOMITANT DEVICES: PFNA NAIL (PART: UNKNOWN, LOT: UNKNOWN: QUANTITY: 1) IMPACTOR (PART: UNKNOWN, LOT: UNKNOWN: QUANTITY: 1) THIS REPORT IS FOR A PFNA BLADE PERF L105 TAN. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503145 PFNA BLADE PERF L105 TAN ROD, FIXATION, INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH L893128 07611819369504

    Patients

    Seq Age Sex Outcome Treatment
    1 THERAPY DATE: JUNE 10, 2018