BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4MM TI VA LOCKING SCREW STARDRIVE 20MM-STERILE

    MDR report key: 8157203 · Received December 12, 2018

    Report

    Report Number
    8030965-2018-58964
    Event Type
    Injury
    Date Received
    December 12, 2018
    Date of Event
    November 9, 2018
    Report Date
    November 21, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    UDI-DI
    07611819980679
    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. SHAFT OF BROKEN SCREW REMAINED IN THE PATIENT. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART: 04.210.120S, LOT: L222863. MANUFACTURING LOCATION: SELZACH, RELEASE TO WAREHOUSE DATE: DEC 06, 2016, EXPIRY DATE: NOV 01, 2026. NON-STERILE PART: 04.210.120, LOT: H229957. MANUFACTURING LOCATION: MONUMENT, MANUFACTURING DATE: NOV 16, 2016. 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. PRODUCT INVESTIGATION WAS COMPLETED. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT ONLY THE HEAD OF THE 2.4MM TI VA LOCKING STARDRIVE SCREW-20MM WAS RETURNED. THE FRACTURE SURFACE AT WHICH THE HEAD BROKE OFF FROM APPEARED HOMOGENOUS WITH NO VOIDS, DARK SPOTS, OR OTHER IRREGULARITIES IN THE METAL. THE STARDRIVE HEAD OF THE SCREW HAD SOME PATIENT DEBRIS AND APPEARED TO BE SLIGHTLY DEFORMED, MOST LIKELY DUE TO THE FORCES UNDERWENT WHEN THE SHAFT OF THE SCREW BROKE OFF FROM THE HEAD. NO FUNCTIONAL TEST COULD BE PERFORMED AS THE VA-LCP DISTAL HUMERUS PLATE WITH WHICH THE LOCKING SCREW ARTICULATES WITH WAS NOT RETURNED. HOWEVER, ALTHOUGH THE COMPLAINT COULD NOT BE REPLICATED DUE TO THE MISSING PLATE, BASED ON THE RESULTS OF THE VISUAL INSPECTION AND THE FACT THAT ONLY THE HEADS OF THE SCREWS COULD BE RETURNED, IT CAN BE DEDUCED THAT THE SCREWS WERE UNABLE TO BE DISASSEMBLED FROM THE CONCOMITANT PLATE. AS THE RECEIVED CONDITION WAS DETERMINED TO AGREE WITH THE COMPLAINT DESCRIPTION, THE COMPLAINT IS CONFIRMED. RELEVANT DRAWINGS, REFLECTING THE CURRENT AND MANUFACTURED REVISION, WERE REVIEWED. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE COMPLAINT CONDITION WAS CONFIRMED AS THE 2.4MM TI VA LOCKING STARDRIVE SCREWS-20MM (04.210.120S, L222863) WAS OBSERVED TO BE BROKEN BECAUSE OF AN INABILITY TO DISASSEMBLE FROM A CONCOMITANT VA-LCP DISTAL HUMERUS PLATE. NO NEW PRODUCT DESIGN ISSUES OR MANUFACTURING DISCREPANCIES WERE IDENTIFIED DURING THIS INVESTIGATION. BASED UPON THE INVESTIGATION FINDINGS, NO ADDITIONAL 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.

    Description of Event or Problem · 0

    THIS COMPLAINT (B)(4) CAPTURES ALL INTRA-OPERATIVE EVENTS WHILE (B)(4) CAPTURES POST-OPERATIVE BREAKAGE OF SCREW EVENT. CONCOMITANT DEVICES: 2.4MM VARIABLE ANGLE LOCKING SCREW L18MM (PART #: 04.210.118S, LOT #: L667991, QUANTITY UNKNOWN), 2.4MM VARIABLE ANGLE LOCKING SCREWS L14MM (PART #: 04.210.114S, LOT #: L298947, QUANTITY: 1), 2.7 MM CORTEX SCREWS L14MM (PART #: 402.874S, LOT #: L615450, QUANTITY: 1) , 2.7 MM CORTEX SCREWS L18MM (PART #: 402.878S, LOT #: L399720, QUANTITY: 1).

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. RECEIVED BUT NOT THE FINAL DESTINATION. (B)(4). A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT UNDERWENT AN EXPLANTATION SURGERY ON (B)(6) 2018. THE PATIENT WAS INITIALLY IMPLANTED WITH A VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) ON (B)(6) 2018 TO TREAT A DISTAL RADIUS FRACTURES. DURING THE PROCEDURE, THE SURGEON TRIED TO REMOVE TWO (2) BROKEN LOCKING SCREWS, HOWEVER, THE HEADS OF THE SCREWS HAD BEEN LOCKED IN THE PLATE, A HOLLOW REAMER NOR AN EXTRACTION SCREW COULD NOT BE USED. THUS, THE SURGEON GAVE UP REMOVING THE SHAFTS OF BROKEN SCREWS, AND DECIDED TO LEAVE THE PLATE AND SCREWS INSIDE THE PATIENT. THERE WAS NO PLAN OF REOPERATION. HOWEVER, IF IRRITATION SYMPTOMS OF THE FLEXOR TENDON APPEAR, IT WILL BE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE SURGERY WAS DELAYED BY MORE THAN 30 MINUTES. PATIENT OUTCOME WAS UNKNOWN.  THIS REPORT IS FOR ONE (1) BROKEN LOCKING SCREW. CONCOMITANT DEVICES REPORTED:  2.4MM VARIABLE ANGLE LOCKING SCREW L18MM (PART #: 04.210.118S, LOT #: L667991, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    996619 2.4MM TI VA LOCKING SCREW STARDRIVE 20MM-STERILE PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH L222863 07611819980679

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention