BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TFNA FENESTRATED SCREW 120MM

    MDR report key: 11631320 · Received April 7, 2021

    Report

    Report Number
    8030965-2021-02692
    Event Type
    Injury
    Date Received
    April 7, 2021
    Date of Event
    March 19, 2021
    Report Date
    March 19, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    UDI-DI
    07611819659797
    PMA / PMN Number
    K160167
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. H3, H6: PART #: 04.038.220, SYNTHES LOT #: N/A, SUPPLIER LOT #: H831526, RELEASE TO WAREHOUSE DATE: FEBRUARY 28, 2019, MANUFACTURED BY: MONUMENT, NO NCR'S GENERATED DURING PRODUCTION. VISUAL INSPECTION: THE TFNA SCR PERF L120 TAN (P/N: 04.038.220, LOT #: H831526) WAS RETURNED AND RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THERE WERE SEVERAL SCRATCHES AND NICKS ON THE DEVICE BUT HAVE NO IMPACT ON THE DEVICE FUNCTIONALITY. ALSO, SOME FOREIGN OBJECT WAS OBSERVED ON THE DEVICE SURFACE. WERE ANY PRODUCT ISSUES/DEFECTS IDENTIFIED? YES. APPROPRIATE INVESTIGATION FLOW: VISUAL. DIMENSIONAL INSPECTION: FEATURE: OUTER DIAMETER MEASURED DIMENSION: CONFORMING RESULT: CONFORMING MEASUREMENT DEVICE: CALIPER. DOCUMENT/SPECIFICATION REVIEW BASED ON THE DATE OF MANUFACTURE, THE CURRENT AND MANUFACTURED REVISION OF DRAWINGS WERE REVIEWED TI TFNA FENSTRATED SCREW NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. COMPLAINT CONFIRMED? YES . INVESTIGATION CONCLUSION THE COMPLAINT CONDITION WAS CONFIRMED FOR THE TFNA SCR PERF L120 TAN (P/N: 04.038.220, LOT #: H831526). THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. THE POTENTIAL CAUSE COULD BE DUE TO UNINTENDED FORCES APPLIED TO THE DEVICE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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

    PRODUCT COMPLAINT#: (B)(4). 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. H10 ADDITIONAL NARRATIVE: E1: UPDATED REPORTER'S NAME PROVIDED. H6: INVESTIGATION SUMMARY: THE COMPLAINT CONDITION COULD BE CONFIRMED ACCORDING TO THE RECEIVED PICTURES. A PIECE, CLOSE TO THE GUIDING HOLE OF THE TFNA NAIL, IS BROKEN OFF. THE TFNA SCREW AND THE LOCKING SCREW ARE ALSO DAMAGED WITH DEEP SCRATCHES AND FLATTENED THREADS. THE END CAP IS NOT VISIBLE ON THE PICTURES/X-RAYS. 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. H3, H4, H6: DEVICE HISTORY LOT: MANUFACTURING LOCATION: ELMIRA / PACKAGED, STERILIZED AND RELEASED BY: MONUMENT, RELEASE DATE: 28-FEB-2019, EXPIRATION DATE: 01-FEB-2029, PART NUMBER: 04.038.220S, TFNA FENESTRATED SCREW 120MM -STERILE, LOT NUMBER: H831526 (STERILE), LOT QUANTITY: 48. NOTE: BLADE WAS MANUFACTURED BY ELMIRA. WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. ELMIRA INSPECTION SHEETS, REV D, MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, FINAL INSPECTION, REV L MET ALL INSPECTION ACCEPTANCE CRITERIA. PACKAGING LABEL LOG (PLL) LMD REV AC WAS REVIEWED AND DETERMINED TO BE CONFORMING. SCN 16052 COULD NOT BE LOCATED FOR REVIEW, HOWEVER, THE LOT WOULD NOT HAVE BEEN RELEASED IF IT HAD NOT MET ALL STERILITY REQUIREMENTS. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE HISTORY BATCH NULL, DEVICE HISTORY REVIEW 25-MAR-2021: DHR REVIEWED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT 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.

    Description of Event or Problem · 0

    UPDATE: THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS 1 OF 4 FOR (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL PROCODE: KTT. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. 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 · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT REMOVAL SURGERY TO HAVE THE TFNA FENESTRATED SCREW, UNKNOWN LOCKING SCREW, UNKNOWN TFNA NAIL, AND UNKNOWN END CAP REMOVED DUE TO INFECTION. THE IMPLANT WAS REMOVED EASILY BUT WAS DAMAGED. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 120MM. THIS IS REPORT 1 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524127 TFNA FENESTRATED SCREW 120MM ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES GMBH H831526 07611819659797

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNK - END CAPS: TFNA| UNK - END CAPS: TFNA| UNK - NAILS: TFNA| UNK - NAILS: TFNA| UNK - SCREWS: NAIL DISTAL LOCKING| UNK - SCREWS: NAIL DISTAL LOCKING