BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFNA BLADE PERF L100 TAN

    MDR report key: 8233456 · Received January 10, 2019

    Report

    Report Number
    8030965-2019-59707
    Event Type
    Injury
    Date Received
    January 10, 2019
    Date of Event
    December 13, 2018
    Report Date
    December 14, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    UDI-DI
    07611819368996
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    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. 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 · 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. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 40 PIECES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2018, DURING AN UNKNOWN SURGERY, A PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) BLADE COULD NOT BE LOCKED. AFTER THE PROCEDURE, THE SALES CONSULTANT TESTED THE HANDLE AND BLADE WITHOUT ANY ISSUES. THE BLADE WAS REPORTED AS FAULTY. THERE WAS NO BREAKAGES NOR CRACKS REPORTED.THE SALES CONSULTANT TOLD THE SURGEON TO CHANGE BLADE, BUT THE SURGEON OPTED TO LEAVE IT IN THE PATIENT (IN SITU). PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: PFNA (PART 472.266S, LOT L963073, QUANTITY 1) GUIDEWIRE (PART 357.399, LOT#UNKNOWN, QUANTITY 2); DRILL (PART 356.834, LOT#UNKNOWN, QUANTITY 1) SCREW (PART 04.005.526, LOT#UNKNOWN, QUANTITY 1).

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (510K): DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. (B)(4). A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 ON (B)(6) 2018, DURING AN UNKNOWN SURGERY, A PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) BLADE WOULD NOT BE LOCKED. AFTER THE CASE, THE SALES CONSULTANT TESTED THE HANDLE AND ANOTHER BLADE WITHOUT ANY ISSUES. THE BLADE ITSELF MUST HAVE BEEN FAULTY. THE SALES CONSULTANT TOLD THE SURGEON TO CHANGE BLADE, BUT THE SURGEON OPTED TO LEAVE IT IN THE PATIENT IN SITU. IT WAS UNKNOWN IF THERE WAS AN ADVERSE EVENT TO THE PATIENT. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY REPORTED. PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: PFNA NAIL (PART 472.266S, LOT L963073, QUANTITY 1). 3.2MM GUIDEWIRE (PART 357.399, LOT # UNKNOWN, QUANTITY 2). DRILL BIT (PART 356.834, LOT # UNKNOWN, QUANTITY 1). LOCKING SCREW (PART 04.005.526, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) PFNA BLADE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28340 PFNA BLADE PERF L100 TAN ROD, FIXATION, INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH L861439 07611819368996

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention