BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5MM TI CORTEX SCREW SELF-TAPPING 7MM

    MDR report key: 6659809 · Received June 22, 2017

    Report

    Report Number
    3000270450-2017-10203
    Event Type
    Malfunction
    Date Received
    June 22, 2017
    Date of Event
    May 25, 2017
    Report Date
    May 25, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HWC
    PMA / PMN Number
    K112583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT¿S DATE OF BIRTH, WEIGHT ARE UNKNOWN. ADDITIONAL DEVICE PRODUCT CODES: MQN, DZL (B)(4). NOT IMPLANTED OR EXPLANTED, PARTIAL DEVICE REMAINED IN PATIENT. COMPLAINANT DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART # 400.807S, LOT # 9133461: PLEASE NOTE, THIS DHR REVIEW IS FOR STERILIZATION PROCEDURE ONLY. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 08.SEP.2014, EXPIRY DATE: 01.AUG.2024: NO NON CONFORMANCE REPORTS (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. NON-STERILE 400.807-EXS/ 9062226: MANUFACTURING LOCATION:(B)(4), MANUFACTURING DATE: 09.JUL.2014: NO NON CONFORMANCE REPORTS (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. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT IS REPORTED THAT DURING A SURGERY ON (B)(6) 2017 TO TREAT THE RIGHT 4TH PROXIMAL PHALANGE FRACTURE, THE SURGEON DRILLED HOLES FOR THE SCREWS. WHEN THE SURGEON INSERTED THE CORTEX SCREWS THROUGH THE MODULAR HAND SYSTEM (MHS) 1.5Y PLATE, THE HEAD OF THE TWO CORTEX SCREWS IN QUESTION WERE BROKEN. PER SURGEON IT WAS DIFFICULT TO REMOVE THE BROKEN PIECE OF THE SCREW TIPS THEREFORE THE SCREWS REMAINED EMBEDDED IN THE BONE. OTHER CORTEX SCREWS IN DIFFERENT SIZE WERE USED TO COMPLETE THE PROCEDURE. PER SURGEON THE SCREW HEAD MIGHT HAVE BROKEN AS THE PATIENT WAS RELATIVELY YOUNG AND HAD GOOD BONE QUALITY. THE SURGEON ALSO POINTED OUT THAT EXTRA LOAD MIGHT HAVE BEEN APPLIED TO THE CORTEX SCREW WHEN THE SURGEON WAS INSERTING THE CORTEX SCREW. THE SURGERY WAS EXTENDED FOR THIRTY (30) MINUTES.CONCOMITANT DEVICE REPORTED: MODULAR HAND SYSTEM (MHS) 1.5Y PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1)THIS REPORT IS FOR ONE (1) 1.5MM TI CORTEX SCREW SELF-TAPPING 7MMTHIS IS REPORT 1 OF 2 FOR COMPLAINT COM-289534

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440500 1.5MM TI CORTEX SCREW SELF-TAPPING 7MM SCREW, FIXATION, BONE HWC SYNTHES SELZACH 9133461

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR