BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK - NAILS: AFN

    MDR report key: 8824123 · Received July 24, 2019

    Report

    Report Number
    8030965-2019-66544
    Event Type
    Malfunction
    Date Received
    July 24, 2019
    Date of Event
    June 28, 2019
    Report Date
    June 28, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    JDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. 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. H10 ADDITIONAL NARRATIVE: H3, H4, H6: 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.

    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. 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

    THE BROKEN RADIOLUCENT DRIVE IS CAPTURED ON RELATED COMPLAINT (B)(4). THIS REPORT CAPTURES THE SECONDARY FRACTURE AND THE DISTAL SCREW WHICH WAS NOT INSERTED COMPLETELY.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN AFN NAIL/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. 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 (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, OSTEOSYNTHESIS SURGERY FOR THE FEMORAL DIAPHYSEAL FRACTURE (AO CLASSIFICATION: TYPE C) WAS PERFORMED WITH EXPERT AFN. AFTER INSERTING TWO SCREWS IN THE DISTAL AREA, THE SURGEON FOUND BY X-RAYS THAT ONE SCREW WAS NOT INSERTED COMPLETELY. HE REMOVED THE SCREW AND DRILLED AGAIN BUT WAS UNABLE TO INSERT ANOTHER SCREW IN THE HOLE. HE DRILLED THROUGH THE REMAINING SCREW HOLE, HOWEVER, THE DRILL INTERFERED WITH THE NAIL AND THE RADIOLUCENT DRIVE BROKE. THE SURGEON INSERTED A SCREW INTO THE HOLE FROM WHICH HE REMOVED THE SCREW. HE HAMMERED A SCREWDRIVER WHICH WAS ATTACHED TO THE SCREW BECAUSE THE SCREW COULD NOT BE INSERTED EASILY. A SECONDARY FRACTURE OCCURRED WHEN HE HAMMERED THE SCREWDRIVER ABOUT FIVE (5) TIMES FORCEFULLY. THE SURGEON WRAPPED THE SECONDARY FRACTURE SITE WITH A NON-SYNTHES CABLE. EVENTUALLY, THE DISTAL LOCKING WAS DONE WITH ONLY ONE SCREW. THE SURGERY WAS DELAYED BY LESS THAN THIRTY (30) MINUTES. THE BROKEN RADIOLUCENT DRIVE IS CAPTURED ON RELATED (B)(4). THE SECONDARY FRACTURE IS CAPTURED ON RELATED (B)(4). THIS COMPLAINT CAPTURES THE DISTAL SCREW WHICH WAS NOT INSERTED COMPLETELY. THIS REPORT IS FOR AN UNKNOWN AFN NAIL. THIS IS REPORT 4 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615875 UNK - NAILS: AFN NAIL, FIXATION, BONE JDS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR