BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 7722918 · Received July 26, 2018

    Report

    Report Number
    8030965-2018-55283
    Event Type
    Injury
    Date Received
    July 26, 2018
    Date of Event
    November 6, 2017
    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 HISTORY RECORD (DHR) REVIEW: PART: 04.211.026S; LOT: L045383; MANUFACTURING SITE: SELZACH; SUPPLIER: FRUEH VERPACKUNGSTECHNIK AG; RELEASE TO WAREHOUSE DATE: 01. JULY 2016; EXPIRY DATE: 01. JUNE 2026. 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 H120580 IS REQUIRED: MANUFACTURING LOCATION: MONUMENT; MANUFACTURING DATE: 10-JUN-2016; PART #: 04.211.026 (EU ITEM NO.) LOT #: H120580; (NON-STERILE) - 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 26 MM; LOT QUANTITY: 236. REVIEW OF THE DHR RECORDS REVEALED ONE NONCONFORMANCE (NC)ASSOCIATED TO PART #: 04.211.026.999 GENERATED FOR BURRS FOUND IN THE DRIVE AND/OR COUNTERSINK OF THE HEAD. THESE BURRS WOULD NOT CAUSE OR CONTRIBUTE TO THE COMPLAINT CONDITION BECAUSE THE MATERIAL AT THE BASE OF THE HEAD WAS NOT NEGATIVELY AFFECTED. PRODUCT WORK ORDER TRAVELER MET ALL ACCEPTANCE INSPECTION CRITERIA WITH A 4 PIECE WEIGHT VARIANCE ACCOUNTED FOR. INSPECTION SHEET FOR MILL SHAFT THREADS, TURN/THREAD HEAD, FLUTE, FINAL INSPECTION MET ALL INSPECTION ACCEPTANCE CRITERIA. PACKAGING LABEL LOG WAS REVIEWED AND FOUND TO BE CONFORMING. COMPONENTS REVIEWED: PART #: 04.211.026.999, 2.8MM TI SCREW BLANK 26MM LOT #: 9818501 BP 55; LOT QUANTITY: 933. NONCOFORMANCE RECORD (NCR) WAS GENERATED AT OP # 30, BAG / LABEL FOR BURRS FOUND IN THE DRIVE AND/OR COUNTERSINK OF THE HEAD. THE LOT WAS 100% INSPECTED AND 16 PIECES WERE SCRAPPED. 941 PIECES WERE RELEASED. THERE WAS AN 8 PIECE WEIGHT VARIANCE ACCOUNTED FOR. 933 PIECES WERE RELEASED TO BLANK STORAGE ON 01-JUN-2015. REVIEW OF THE NC WITH ENGINEERING INDICATED THAT THE NONCONFORMANCE OF BURRS AT THE DRIVE AND/OR COUNTERSINK WOULD NOT HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT CONDITION. PART #: 04.210.120.999, 2.8MM SCREW BLANK 31MM NO HEAD TURN/NO POINT W/SD8 LOT #: 7879272 BP 55 LOT QUANTITY: 957; PRODUCT WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. 957 PIECES WERE RELEASED TO BLANK STORAGE ON 22-DEC-2014; PART #: 23032 TIALNBC12.78 LOT #: 6916371 BP 80; LOT QUANTITY: 246 LBS. PRODUCT TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. CERTIFIED TEST REPORT RECEIVED FROM PERRYMAN DATED 24-JAN-2012 WAS REVIEWED AND FOUND TO BE CONFORMING.INSPECTION CERTIFICATE SUPPLIED BY VSMPO DATED 31-OCT-2011 WAS REVIEWED AND FOUND TO BE CONFORMING. RAW MATERIAL RECEIVING / PUTAWAY CHECKLIST MET ALL INSPECTION ACCEPTANCE CRITERIA. 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. 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) 2017. DURING THE SURGERY, THE PATIENT WAS IMPLANTED WITH TWO (2) VARIABLE ANGLE (VA) LOCKING SCREWS AT THE PROXIMAL AREA. ON THE FOLLOWING DAY, 100% WEIGHT BEARING WAS STARTED. ON (B)(6) 2017, THE SCREWS WERE BROKEN UNDER THEIR HEADS. AT THAT TIME, BONE HEALING WAS IN PROGRESS, THUS, CONSERVATIVE TREATMENT WAS APPLIED. THE SYMPTOM HAS ALREADY HEALED, AND THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564542 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 26MM SCREW, FIXATION, BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH L045383 07611819444195

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention