BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTION SLEEVE F/NAILS Ø8-11 FLEX LON

    MDR report key: 19441327 · Received May 31, 2024

    Report

    Report Number
    8030965-2024-06982
    Event Type
    Injury
    Date Received
    May 31, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    UDI-DI
    07612334171122
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. DEVICE HISTORY RECORD (DHR) REVIEW CONDUCTED: PART # 03.043.033S LOT # 10367007 MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE : 15.SEP.2023 EXPIRATION DATE: 01SEP.2028 SUPPLIER: GEMÜ GMBH A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. 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.

    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. H11 ADDITIONAL NARRATIVE: CORRECTED: D4 (PRIMARY UDI NUMBER), E4, H8. 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 AN UNKNOWN DATE DURING THE PROCEDURE THE METAL INNER LINING OF A SUPRAPATELLAR SLEEVE HAD SEPARATED FROM THE PLASTIC CASING AND WAS TRAPPED IN THE PATIENTS TIBIA. PER SURGEON AN EXPERT SLEEVE WAS USED TO REAM THROUGH AND THAT THE ANS SUPRAPATELLAR SLEEVE WAS ONLY USED TO INSERT THE NAIL. IN ORDER TO REMOVE THE TRAPPED METAL LINING THE SURGEON PERFORMED A LATERAL PARAPATELLAR INCISION TO GAIN MORE ACCESS TO THE DISTAL END OF THE SLEEVE. PATIENT ENDED UP HAVING A LATERAL PARAPATELLAR INCISION AND POSSIBLE DAMAGED TO THE PATELLA FEMORAL JOINT. THERE WAS SURGICAL DELAY. THIS REPORT IS FOR ONE (1) PROTECTION SLEEVE/ FLEX/ LONG FOR NAILS Ø 8-11MM / STERILE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299693 PROTECTION SLEEVE F/NAILS Ø8-11 FLEX LON ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SYNTHES GMBH 10367007 07612334171122

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention UNK - NAIL.