BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4MM TI VA LOCKING SCREW STARDRIVE 20MM-STERILE

    MDR report key: 8156989 · Received December 12, 2018

    Report

    Report Number
    8030965-2018-58959
    Event Type
    Injury
    Date Received
    December 12, 2018
    Date of Event
    January 1, 2018
    Report Date
    November 21, 2018
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. ADDITIONAL INFORMATION PROVIDED. PLEASE NOTE, THIS DEVICE HISTORY RECORD (DHR) REVIEW IS FOR STERILIZATION PROCEDURE ONLY: PART: 04.210.120S; LOT: L222863; MANUFACTURING LOCATION: SELZACH; SUPPLIER: FRUEH AG; RELEASE TO WAREHOUSE DATE: DECEMBER 06, 2016; EXPIRY DATE: NOVEMBER 01, 2026 NON-STERILE 04.0210.120 / H229957 WAS MANUFACTURED IN US, MONUMENT; MANUFACTURING DATE: NOVEMBER 16, 2016; PART: 04.210.120; 2.4MM TI VA LOCKING SCREW STARDRIVE 20MM; LOT: H229957 (NON-STERILE); LOT QUANTITY: 240 WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. FOUR PIECES WERE SCRAPPED IN CELL AT MILL SHAFT THREADS / HEAD THREADS / FLUTE AFTER BEING DROPPED. INSPECTION SHEET, MILL SHAFT THREAD / HEAD THREAD / FLUTE MET ALL INSPECTION ACCEPTANCE CRITERIA. PACKAGING LABEL LOG LPPF, LMD/LPF WAS REVIEWED AND DETERMINED TO BE CONFORMING. 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: 04.211.020.999; 2.8MM TI SCREW BLANK 20MM 2.7 VARIABLE ANGLE W/SD8; LOT: H227813; LOT QUANTITY: 724 WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. PART: 04.210.120.999; SCREW BLANK 31MM NO HEAD TURN/NO POINT W/SD8; LOT: H196243; LOT QUANTITY: 724 WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. PART: 23032; TIALNBCI2.78; LOT: 6947537; LOT QUANTITY: 1,150 LBS. BP80 PRODUCT TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. PRODUCT CERTIFICATION RECEIVED FROM DYNAMET WAS REVIEWED AND DETERMINED TO BE CONFORMING. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MET ALL INSPECTION ACCEPTANCE CRITERIA. 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 EVALUATION: BROKEN VISUAL INSPECTION: UPON VISUAL INSPECTION, IT WAS OBSERVED THAT ONLY THE HEAD OF THE 2.4MM TITANOUM (TI) VARIABLE ANGLE (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 UNDERGONE WHEN THE SHAFT OF THE SCREW BROKE OFF FROM THE HEAD. THE RECEIVED CONDITION WAS DETERMINED TO AGREE WITH THE COMPLAINT DESCRIPTION. AS SUCH, THE COMPLAINT HAS BEEN CONFIRMED. DIMENSIONAL INSPECTION: DUE TO POST-MANUFACTURING DEFORMATION, DIMENSIONAL INSPECTION WAS UNABLE TO BE CONDUCTED. DURING THE DOCUMENT/SPECIFICATION REVIEW, THE FOLLOWING DRAWINGS, REFLECTING THE CURRENT AND MANUFACTURED REVISION, WERE REVIEWED. -- 2.4MM VARIABLE ANGLE LOCKING SCREW SELF-TAPPING, STARDRIVE RECESS 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. INVESTIGATION CONCLUSION: THE COMPLAINT CONDITION WAS CONFIRMED AS THE 2.4MM TI VA LOCKING STARDRIVE SCREWS-20MM (04.210.120S, L222863) WERE OBSERVED TO BE BROKEN BECAUSE OF AN INABILITY TO DISASSEMBLE FROM A CONCOMITANT VA LOCKING COMPRESSION PLATE (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

    CONCOMITANT DEVICES: VA-LCP DISTAL HUMERUS PLATE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). 2.4MM VARIABLE ANGLE LOCKING SCREW 18MM (PART: 04.210.118S, LOT: L667991, QUANTITY: 1). 2.4MM VARIABLE ANGLE LOCKING SCREW 14MM (PART: 04.210.114S, LOT: L298947, QUANTITY: 1). 2.7MM CORTEX SCREW 14MM (402.874, LOT L615450, QUANTITY 1). 2.7MM CORTEX SCREW 18MM (402.878, 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. (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 ON (B)(6) 2018, THE PATIENT UNDERWENT AN EXPLANT SURGERY DUE TO AN UNKNOWN REASON, AND TWO (2) VARIABLE ANGLE LOCKING SCREWS WERE FOUND BROKEN. THE SURGEON UNDERSTANDS THAT POSTOPERATIVE MICRO MOTION OR IMPROPER REDUCTION AFTER THE SURGERY CAN BE A FACTOR OF THE EVENT. ORIGINALLY, ON (B)(6) 2018, THE PATIENT WAS IMPLANTED WITH VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) FOR DISTAL RADIUS FRACTURES. BONE HEALING AT THE AFFECTED SITE HAS ALREADY OCCURRED. THERE WAS MORE THAN 30 MINUTES SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICES REPORTED: VA-LCP DISTAL HUMERUS PLATE (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: 1) AND 2.4MM VARIABLE ANGLE LOCKING SCREW L18MM (PART #: 04.210.118S, LOT #: L667991, QUANTITY: 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    995110 2.4MM TI VA LOCKING SCREW STARDRIVE 20MM-STERILE PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH L222863

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention