BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 26MM

    MDR report key: 7723050 · Received July 26, 2018

    Report

    Report Number
    8030965-2018-55284
    Event Type
    Injury
    Date Received
    July 26, 2018
    Date of Event
    July 6, 2018
    Report Date
    July 9, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    UDI-DI
    07611819444195
    PMA / PMN Number
    K100776
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. DEVICE HIOSTORY RECORD (DHR) REVIEW: PART: 04.211.026S; LOT: L898301; MANUFACTURING SITE: SELZACH; SUPPLIER: FRUEH VERPACKUNGSTECHNIK AG; RELEASE TO WAREHOUSE DATE: 22. MAY 2018; EXPIRY DATE: 01. MAY. 2028. PART WAS ONLY PACKED AND STERILIZED AT SYNTHES GMBH AND AS THIS COMPLAINT IS NEITHER PACKAGING NOR STERILIZATION RELATED NO REVIEW OF THESE DOCUMENTS IS NECESSARY. US DHR REVIEW FOR UNSTERILE PART 04.211.026 WITH LOT H572353 IS REQUIRED: ITEM: 04.211.026; LOT: H572353; MFG: 238; MFG DATE: 20 FEB 2018; MFG LOCATION: MONUMENT. PRODUCT WAS INSPECTED PER RELEVANT INSPECTION SHEET. THIS PRODUCT IS MADE FROM COMPONENT ITEM 04.211.026.999. ITEM: 04.211.026.999; LOT: H503103; MFG QTY: 950; MFG DATE: 08 NOV 2017; MFG LOCATION: MONUMENT. PRODUCT WAS INSPECTED AND PASSED PER RELEVANT INSPECTION SHEET. THIS LOT WAS MADE FROM COMPONENT ITEM 04.210.120.999. ITEM: 04.210.120.00; LOT: H497760; MFG QTY: 956; MFG DATE: 06 NOV 2017. PRODUCT WAS INSPECTED AND PASSED PER PROCESS SHEET CRITERIA. LOT WAS MADE FROM RAW MATERIAL ITEM 23032. RAW MATERIAL ITEM: 23032; LOT: H494830; QTY REC'D: 694 POUNDS; REC'D DATE: 30 OCT 2017; MANUFACTURER: PERRYMAN CORP. CERTIFICATIONS RECEIVED FROM PERRYMAN AND RAW MATERIAL RECEIVING/PUT AWAY CHECKLIST INDICATE THAT MATERIAL MEETS SPECIFICATIONS. THERE WERE NO NCS OR REWORKS NOTED IN ANY OF THE DHRS. NO NONCONFORMANCE RECORDS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT 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

    THIS PATIENT INFORMATION IS UNKNOWN. ADDITIONAL DEVICE PRODUCT CODE: HRS. UNKNOWN IF THE REOPERATION WAS PERFORMED ON (B)(6) 2018. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED AND IS CURRENTLY PENDING COMPLETION. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT UNDERWENT THE MANN METHOD TO TREAT THE HALLUX VALGUS OF THE FIRST METATARSAL BONE ON (B)(6) 2018. DURING THE SURGERY, THE PATIENT WAS IMPLANTED WITH TWO (2) VARIABLE ANGLE (VA) LOCKING SCREWS AT THE PROXIMAL AREA. ON THE FOLLOWING DAY, FULL WEIGHT BEARING WAS STARTED. ON (B)(6) 2018, THE SCREWS WERE BROKEN UNDER THEIR HEADS. FRAGMENTS REMAINED IN THE PATIENT¿S BODY. THE PATIENT WAS SCHEDULED FOR REOPERATION ON (B)(6) 2018. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563865 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 26MM SCREW, FIXATION, BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH L898301 07611819444195

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention