BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VA-LCP OLECR PL 2.7/3.5 LE 2HO L90 TAN

    MDR report key: 9369443 · Received November 25, 2019

    Report

    Report Number
    8030965-2019-70555
    Event Type
    Injury
    Date Received
    November 25, 2019
    Date of Event
    November 7, 2019
    Report Date
    November 7, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    UDI-DI
    07611819504677
    PMA / PMN Number
    K120070
    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. DEVICE HISTORY LOT. MANUFACTURING LOCATION: ELMIRA / MONUMENT. MANUFACTURING DATE: MAY 24, 2019. EXPIRATION DATE: APR 01, 2029. PART NUMBER: 04.107.302S, 2.7MM/3.5MM TI VA-LCP OLECRANON PL 2H/LT/90MM-STERILE. LOT NUMBER: H873407 (STERILE). LOT QUANTITY: 60. WORK ORDER AND PRODUCTION ORDER TRAVELERS MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, DIMENSIONAL INSPECTION, NS062275 REV E MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, FINAL INSPECTION, NS055540 REV F MET ALL INSPECTION ACCEPTANCE CRITERIA. PACKAGING LABEL LOG (PLL) LMD REV AD WAS REVIEWED AND DETERMINED TO BE CONFORMING. SCN 16253 SUPPLIED BY STERIGENICS WAS REVIEWED AND DETERMINED TO BE CONFORMING. THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILITY AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE HISTORY REVIEW NOV 21, 2019: DHR REVIEWED . THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILITY 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.

    Additional Manufacturer Narrative · 1

    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. (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 SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT OSTEOSYNTHESIS SURGERY FOR PROXIMAL ULNA FRACTURE WITH THE VA OLECRANON PLATE AND THE VA LOCKING SCREW IN QUESTION. DURING THE SURGERY, THE SURGEON COULD NOT LOCK THE SCREW. WHEN THE SURGEON REMOVED THE PLATE ONCE, AND HE CHECKED THE SCREW HOLE, HE FOUND THAT THE THREAD OF THE SCREW HOLE WORN. THE SURGEON GAVE UP INSERTING THE SCREW INTO THE SCREW HOLE. THE SURGEON ASSUMED THAT THE SCREW HOLE WAS DAMAGED WHEN THE DRILL GUIDE WAS ATTACHED TO THE PLATE OR DURING SCREW INSERTION. THE SURGEON SAID THAT FIXABILITY IS NO PROBLEM. THE SURGERY WAS DELAYED BY LESS THAN 30 MINUTES. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN INSERTION INSTRUMENT (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), UNKNOWN DRILL GUIDE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS IS 2 OF 2 FOR REPORT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1162466 VA-LCP OLECR PL 2.7/3.5 LE 2HO L90 TAN PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH H873407 07611819504677

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNK - INSERTION INSTRUMENTS: TRAUMA| UNKNOWN DRILL GUIDE