BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: LOCKING

    MDR report key: 10326489 · Received July 27, 2020

    Report

    Report Number
    8030965-2020-05279
    Event Type
    Injury
    Date Received
    July 27, 2020
    Report Date
    May 5, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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 · 1

    THIS REPORT IS FOR AN UNKNOWN LOCKING SCREW/ UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/ INVESTIGATION. (B)(4). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. 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 UNKNOWN DATE, THAT THE DOCTOR WAS REQUESTING A LARGER LATERAL FEMORAL NAIL (LFN) FOR A POST-OP PROCEDURE. THE DOCTOR¿S JUSTIFICATION FOR THE REQUESTS WAS THAT, THE LFN IMPLANTED IN THE PATIENT IN (B)(6) 2018, NEEDS TO BE REPLACED WITH AN LFN WITH A LARGER CALIBER TO AVOID FATIGUE AND FRACTURE OF THE FEMORAL NECK. FURTHER IT WAS REPORTED ON (B)(6) 2020 THAT THE PATIENT OPTED FOR REPLACING THE MORE CALIBRATED NAIL AND REAMING THE CANAL AS A TREATMENT DUE TO PSEUDOARTHROSIS OF THE RIGHT DIAPHYSEAL FEMUR. WITHDRAWN STEM DID NOT PRESENT ANY PROBLEM OR FAILURE CONCOMITANT DEVICES REPORTED: 11MM TI LATERAL ENTRY FEMORAL RECON NAIL-EX/340MM/RT (PART NUMBER 04.003.448, LOT 9654236, QUANTITY 1), END CAPS: LFN (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) UNKNOWN LOCKING SCREW. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794570 UNK - SCREWS: LOCKING SCREW, FIXATION, BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPERT LFN Ø11 R CANN L340 TAN| UNK - END CAPS: LFN| EXPERT LFN Ø11 R CANN L340 TAN| UNK - END CAPS: LFN