BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL NAIL-ADVANCED / 12MM 345MM / STERILE

    MDR report key: 17548589 · Received August 15, 2023

    Report

    Report Number
    8030965-2023-10297
    Event Type
    Malfunction
    Date Received
    August 15, 2023
    Date of Event
    July 31, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDS
    UDI-DI
    10886982298089
    PMA / PMN Number
    K201336
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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. H3, H4, H6: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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 HISTORY LOT: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE: 04.043.435S -US, LOT NUMBER# 613P388. IT WAS ELECTRONICALLY REVIEWED, AND NO NONCONFORMANCS/MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON: 08/02/2022. MANUFACTURING SITE: JABIL BETTLACH EXPIRY DATE:31/12/2031. 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: D2: ADDITIONAL PROCODE: HWC D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. D10: DATE OF CONCOMITANT THERAPY IS 31-JULY-2023. H3, H6: 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 · 0

    IT WAS REPORTED THAT ON (B)(6) 2023, THE PIN HAD FALLEN OUT OF THE TNA DRIVING CAP. DURING THE PROCEDURE, A TNA NAIL WAS INSERTED, BUT THEN REMOVED TO DIAL IN THE REDUCTION. WHEN THE NAIL WAS EXTRACTED, IT WAS NOTICED THAT THE POLY INSERTED DISTALLY HAD MOVED OUTSIDE OF THE NAIL, THE SURGICAL TECH WAS NOT ABLE TO PUT BACK INTO THE NAIL, AND A NEW NAIL WAS SELECTED. THIS NAIL WAS ALSO EXTRACTED FOR REPOSITIONING AND THE SLEEVE HAD MOVED AS WELL, BUT SURGEON DECIDED TO MOVE FORWARD AND DRILL THROUGH THE POLY INSERT. ADDITIONALLY, THE SURGEON WAS HAVING ISSUES INSERTING THE NAIL THROUGH THE SUPRAPATELLAR PROTECTION SLEEVE, SO IT WAS REMOVED AND THE NAIL WAS INSERTED WITHOUT THE SLEEVE. DURING THE SURGERY, THE SURGEON USED A DRILL BIT IN A ¿BLOCKING¿ FASHION TO REDIRECT THE NAIL, BUT THE DRILL BIT WAS UNABLE TO REMAIN STABLE BECAUSE OF THE COMMINUTION. THEN A BLOCKING SCREW WAS USED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TIBIAL NAIL-ADVANCED / 12MM 345MM / STERILE. THIS IS REPORT 1 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1707415 TIBIAL NAIL-ADVANCED / 12MM 345MM / STERILE NAIL, FIXATION, BONE JDS SYNTHES GMBH 613P388 10886982298089

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male 14.5 OUTER PROTEC SLV SUPRAPATELLAR -S| 4.2 3-FLTD DRILL BIT QC/NEEDLE PT/145| DRIVING CAP| TIBIAL NAIL-ADVANCED / 12 345 / STERILE| UNK - SCREWS: TRAUMA