BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM TI CORTEX SCREW SELF-TAPPING 30MM

    MDR report key: 6689044 · Received July 6, 2017

    Report

    Report Number
    3009450884-2017-10089
    Event Type
    Malfunction
    Date Received
    July 6, 2017
    Date of Event
    June 8, 2017
    Report Date
    June 8, 2017
    Manufacturer
    SYNTHES GRENCHEN
    Product Code
    HWC
    UDI-DI
    07611819201002
    PMA / PMN Number
    K112583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT ID, DATE OF BIRTH/AGE AND WEIGHT WERE NOT PROVIDED FOR REPORTING. ADDITIONAL DEVICE PRODUCT CODES KTT, HRS. IMPLANT AND EXPLANT DATES: DEVICE MALFUNCTIONED INTRAOPERATIVE. DEVICE WAS NOT IMPLANTED/EXPLANTED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. INITIAL REPORTER FACILITY CONTACT NUMBER: (B)(6). DEVICE HISTORY RECORDS (DHR) REVIEW WAS COMPLETED FOR PART# 414.830, LOT# L266591. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: JAN 09, 2017. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DHR REVIEW HAS SHOWN THAT THIS SCREW WAS MADE OUT OF BLANK 414.030.999 WITH LOT H181585. DEVICE HISTORY RECORDS (DHR) REVIEW WAS COMPLETED FOR BLANK PART# 414.030.999 LOT# H181585. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: MOVED TO BLANK STORAGE ON OCT 13, 2016. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. COMPONENTS PART 23018 LOT 7822880 MEET SPECIFICATION. RAW MATERIAL WAS RECEIVED FROM (B)(4). (SUPPLIER LOT: HC-15622). CERTIFICATE TEST REPORT AND RECEIVED FROM (B)(4) CASTINGS FOR TITANIUM IN GOT MEET SPECIFICATION. RAW MATERIAL RECEIVING/PUT AWAY CHECKLIST MEETS REQUIREMENTS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2017, TWO CORTEX SCREWS BROKE DURING INSERTION IN A PERIPROSTHETIC CASE. BOTH SCREWS WERE INSERTED IN TO CEMENT MANTLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE LOCKING PORTION OF THE HOLE WITH LOCKING SCREWS. THE SURGERY WAS NOT PROLONGED AND NO SCREW TIPS WERE LEFT IN THE PATIENT. THE PATIENT OUTCOME WAS REPORTED AS FINE. THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472353 4.5MM TI CORTEX SCREW SELF-TAPPING 30MM SCREW,FIXATION,BONE HWC SYNTHES GRENCHEN L266591 07611819201002

    Patients

    Seq Age Sex Outcome Treatment
    1