BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK - NAILS

    MDR report key: 9904377 · Received March 31, 2020

    Report

    Report Number
    8030965-2020-02443
    Event Type
    Malfunction
    Date Received
    March 31, 2020
    Date of Event
    February 28, 2020
    Report Date
    March 4, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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.

    Description of Event or Problem · 0

    PATIENT'S OUTCOME IS REPORTED AS STABLE. CONCOMITANT DEVICES REPORTED: CONNECT-SCR-CANN F/PFN+PFNA (PART# 357.029, LOT# 2223477, QUANTITY# 1); INSERT-HANDLE RADIOLUC F/PFNA (PART # 03.010.405, LOT # 7595885, QUANTITY 1), PROTECT SLEEVE 11/8 L188 (PART # 03.025.040, LOT # L561859, QUANTITY 1), DRILL BIT Ø4.2 CALIBR L340 3FLUTE F/03.0 (PART # 03.010.061, LOT # L810568, QUANTITY 1), DRILLSL 8/4.2 F/03.010.063 (PART # 03.010.065, LOT # L491756, QUANTITY 1), TROCAR Ø4.2 F/03.010.065 (PART # 03.010.070, LOT # L674743, QUANTITY 1), AIM-ARM 125° F/PFNA BLADE (PART # 03.010.406, LOT # L664518, QUANTITY 1).

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNK - NAILS: UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; 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 ON (B)(6) 2020, THE PATIENT UNDERWENT A SURGERY. DURING THE SURGERY, THE DRILL BIT INTERFERED WITH THE NAIL. THE SURGEON DRILLED A PILOT HOLE WITH A K-WIRE, AND HE COULD DRILL AND INSERT A SCREW. THE SURGEON DIDN¿T KNOW CONCRETE MALFUNCTION OF THE DEVICES. IT WAS NOT REPORTED HOW THE SURGERY WAS COMPLETED. THE SURGICAL DELAY WAS UNKNOWN. CONCOMITANT DEVICES REPORTED: CONNECT-SCR-CANN F/PFN+PFNA (PART# 357.029, LOT# 2223477, QUANTITY# 1). THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS IS REPORT 7 OF 7 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369599 UNK - NAILS ROD, FIXATION, INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 AIM-ARM 125° F/PFNA BLADE| AIM-ARM 125° F/PFNA BLADE| CONNECT-SCR-CANN F/PFN+PFNA| CONNECT-SCR-CANN F/PFN+PFNA| DRILL BIT Ø4.2 CALIBR L340 3FLUTE F/03.0| DRILL BIT Ø4.2 CALIBR L340 3FLUTE F/03.0| DRILLSL 8/4.2 F/03.010.063| DRILLSL 8/4.2 F/03.010.063| INSERT-HANDLE RADIOLUC F/PFNA| INSERT-HANDLE RADIOLUC F/PFNA| PROTECT SLEEVE 11/8 L188| PROTECT SLEEVE 11/8 L188| TROCAR Ø4.2 F/03.010.065| TROCAR Ø4.2 F/03.010.065| UNK - NAILS