BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKSCR Ø5 SELF-TAP L22 TAN

    MDR report key: 7957162 · Received October 11, 2018

    Report

    Report Number
    8030965-2018-57210
    Event Type
    Injury
    Date Received
    October 11, 2018
    Report Date
    September 25, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    UDI-DI
    07611819268760
    Adverse Event
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 413.322S. LOT: 9254169. MANUFACTURING SITE: BETTLACH. SUPPLIER: (B)(4). RELEASE TO WAREHOUSE DATE: 27.NOV.2014. EXPIRY DATE: 01.NOV.2024. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 120 PIECES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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. ADDITIONAL NARRATIVE: B5. 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 IS UNKNOWN IF THE SCREWS WERE EXPLANTED OR IF THEY ARE STILL IMPLANTED.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. 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. A DEVICE HISTORY RECORD REVIEW HAS BEEN REQUESTED. (B)(4). 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 (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIGH TIBIAL OSTEOTOMY DUE TO GONARTHROSIS ON (B)(6) 2018. DURING THE PROCEDURE, A K-WIRE WAS INSERTED FROM THE MEDIAL SIDE OF THE TIBIA. THE BONE WAS CUT WITH A SAGITTAL SAW. FIVE (5) SLAT CHISELS WERE INSERTED INTO THE AFFECTED SITE. A TOMOFIX ANATOMICAL PLATE WAS USED TO FIX THE AFFECTED SITE. ON (B)(6) 2018, PATIENT HAD COMPARTMENT SYNDROME WHICH PROMPTED AN URGENT RELIEF INCISION. THE SURGEON THINKS THAT THE EVENT WAS DUE TO THE DAMAGE OF THE MEDIAL INFERIOR ARTERY OF THE KNEE DURING THE INITIAL SURGERY DUE TO THE BONE SAW OR A MUSCLE HOOK. THE PATIENT EXPERIENCED SLIGHT PARALYSIS ASSOCIATED WITH COMPARTMENT SYNDROME. PATIENT REMAINS IN THE HOSPITAL WITH SIGNS OF COMPARTMENT SYNDROME ON THE LATERAL POSTERIOR SIDE. THE PATIENT WILL BE MONITORED FOR TWO WEEKS. AFTER MUSCULAR ATROPHY OCCURS, ADDITIONAL TREATMENT WILL BE PERFORMED. CONCOMITANT DEVICE: K-WIRE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A LOCKING SCREW. THIS IS REPORT 2 OF 10 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798057 LOCKSCR Ø5 SELF-TAP L22 TAN SCREW, FIXATION, BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH 9254169 07611819268760

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention SEE DESCRIPTION.