BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4MM TI VA LOCKING SCREW STARDRIVE 24MM-STERILE

    MDR report key: 8566347 · Received April 30, 2019

    Report

    Report Number
    8030965-2019-63303
    Event Type
    Injury
    Date Received
    April 30, 2019
    Report Date
    April 1, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    PMA / PMN Number
    K102694
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: THIS MRE REVIEW IS FOR STERILIZATION PROCEDURE ONLY PART: 04.210.124S. LOT: L181133 . MANUFACTURING SITE: SELZACH . SUPPLIER: FRÜH VERPACKUNGSTECHNIK AG . RELEASE TO WAREHOUSE DATE: 02.NOVEMBER 2016. EXPIRY DATE: 01.OCTOBER 2026. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. NON-STERILE PART 04.210.124 / LOT H200244 WAS MANUFACTURED IN MONUMENT US. MANUFACTURING LOCATION: MONUMENT . MANUFACTURING DATE: 11-OCT-2016. PART NUMBER: 04.210.124, 2.4MM TI VA LOCKING SCREW STARDRIVE 24MM. LOT NUMBER: H200244 (NON-STERILE). LOT QUANTITY: 235 . 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. COMPONENT(S) REVIEWED: PART NUMBER: 04.211.024.999, 2.8MM TI SCREW BLANK 24MM 2.7 VARIABLE ANGLE W/SD8. LOT NUMBER: H162712. LOT QUANTITY: 866. PART NUMBER: 04.210.120.999, SCREW BLANK 31MM NO HEAD TURN/NO POINT W/SD8. LOT NUMBER: H151722. LOT QUANTITY: 948. WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA . PART NUMBER: 23032, TIALNBCI2.78. LOT NUMBER: 6947537. LOT QUANTITY: 1,150 LBS. 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. A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE 2.4MM TI VA LOCKING SCREW STARDRIVE 24MM-STERILE (P/N 04.210.124S LOT L181133) WAS RETURNED AND RECEIVED AT US CQ. THE SCREW HEAD WAS OBSERVED TO BE COMPLETELY BROKEN OFF FROM THE SCREW SHAFT AT THE NECK. THE THREADS ON THE SCREW HEAD AND THE 5 MOST PROXIMAL THREADS ON THE SCREW SHAFT ARE STRIPPED, MOST LIKELY DUE TO THE BREAKAGE OF THE SCREW HEAD FROM THE SHAFT AND REMOVAL. NO OTHER ISSUES WERE IDENTIFIED WITH THE RETURNED COMPONENTS OF THE DEVICE. DIMENSIONAL INSPECTION: DIMENSIONAL ANALYSIS COULD NOT BE PERFORMED AS RELEVANT FEATURES ARE DEFORMED THROUGH POST MANUFACTURING DAMAGE. INVESTIGATION CONCLUSION: THE COMPLAINT IS CONFIRMED FOR THE 2.4MM TI VA LOCKING SCREW STARDRIVE 24MM-STERILE (P/N 04.210.124S LOT L181133) AS THE SCREW HEAD WAS OBSERVED TO BE COMPLETELY BROKEN OFF FROM THE SCREW SHAFT. THE THREADS ON THE SCREW HEAD AND THE 5 MOST PROXIMAL THREADS ON THE SCREW SHAFT ARE STRIPPED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED, IT IS POSSIBLE THAT CONDITION WAS DUE TO EARLY EXCESSIVE STRAIN BY PATIENT OR THE SCREWS INCORRECTLY LOCKED TO PLATE (NOT PROPERLY TORQUED). 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

    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. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 · 1

    POTENTIAL LOT NUMBER: L181133 OR L748636 OR L884282. DEVICE AVAILABLE FOR EVALUATION: COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. DEVICE EVALUATED BY MFR: 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 (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A HARDWARE REMOVAL DUE TO BONE UNION. INITIALLY, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) WITH AN UNKNOWN VARIABLE ANGLE (VA) RIM PLATE WAS APPLIED TO SURGERY FOR DISTAL RADIUS FRACTURE ON (B)(6) 2018. HOWEVER, A BONE UNION WAS OBSERVED AFTER SURGERY AND A RE-OPERATION FOR REMOVING THE IMPLANTS WAS PERFORMED. DURING THE RE-OPERATION, IT WAS FOUND THAT THE SECOND AND THIRD VA LOCKING SCREWS FROM THE ULNA SIDE ON THE MOST DISTAL ROW OF THE PLATE HAD BROKEN UNDER SCREW HEADS. THE BROKEN PIECES OF THE SCREWS WHICH HAD BEEN REMAINING IN THE BONE WERE REMOVED SUCCESSFULLY; NO PIECES REMAINED IN THE PATIENT WHICH WAS CONFIRMED BY X-RAY. THE RE-OPERATION WAS COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICE REPORTED: VARIABLE ANGLE LOCKING COMPRESSION PLATE VOLAR RIM (PART 04.115.850S, LOT L363288, QUANTITY 1). THIS REPORT IS FOR A VA LOCKING SCREW. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360182 2.4MM TI VA LOCKING SCREW STARDRIVE 24MM-STERILE PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH L181133

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention VA-LCP VOLAR RIM DIST-RAD-PL2.4 R SHAFT