BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.2MM GUIDE WIRE 400MM

    MDR report key: 7726307 · Received July 27, 2018

    Report

    Report Number
    8030965-2018-55309
    Event Type
    Injury
    Date Received
    July 27, 2018
    Date of Event
    July 10, 2018
    Report Date
    July 10, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    LXH
    UDI-DI
    07611819384194
    PMA / PMN Number
    EXEMPT
    Adverse Event
    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: 357.399S; LOT: L716281; MANUFACTURING SITE: SELZACH; SUPPLIER: FRUEH VERPACKUNGSTECHNIK AG; RELEASE TO WAREHOUSE DATE: JANUARY 08, 2018; EXPIRY DATE: DECEMBER 01, 2027. 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. DHR REVIEW FOR NON-STERILE PART 357.399 WITH LOT H517097: PART NUMBER: 357.399; LOT NUMBER: H517097; PART MANUFACTURING DATE: 8 DECEMBER 2017; MANUFACTURING SITE: ELMIRA; PART EXPIRATION DATE: N/A; NONCONFORMANCE NOTED: N/A. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS LOT H517097 OF 3.2 MM GUIDE WIRES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMANCES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE COMPONENT DEVICE HISTORY RECORD(S) DETERMINED THE COMPONENT LOT H494696 MET ALL SPECIFICATIONS WITH NO ISSUES DOCUMENTED THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD(S) DETERMINED THE RAW MATERIAL LOT H430617 MET ALL SPECIFICATIONS WITH NO ISSUES DOCUMENTED THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE 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

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. IT IS UNKNOWN IF THE COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. 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. 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 THE OPEN REDUCTION INTERNAL FIXATION WAS APPLIED TO FEMORAL NECK FRACTURES ON (B)(6) 2018. THE SURGEON PERFORMED FROM THE GUIDE WIRE INSERTION UP TO THE REAMING. THEN, THE GUIDE WIRE CAME OFF, SO THE SURGEON MADE THE TREADS OF THE GUIDE WIRE TO FACE HIM, AND MANUALLY PUSHED IT BACK TO THE BONE. WHEN A BOLT AND AN FIXATION NAIL SYSTEM (FNS) PLATE WERE INSERTED TO THE BONE, THE TREADS OF THE GUIDE WIRE CAME OUT OF THE INSERTER AND THE GUIDE WIRE GOT STUCK IN THE SURGEON¿S HAND. ALTHOUGH HOW THE SURGEON COPED WITH THE EVENT WAS NOT DETAILED, THE REST OF THE SURGERY WAS COMPLETED WITH A THIRTY (30) MINUTE DELAY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICE: FNS BOLT (PART/LOT UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569117 3.2MM GUIDE WIRE 400MM MISC ORTHO SURGICAL INSTR LXH OBERDORF SYNTHES PRODUKTIONS GMBH L716281 07611819384194

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention