BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5MM TI CORTEX SCREW SELF-TAPPING 12MM

    MDR report key: 4771768 · Received May 14, 2015

    Report

    Report Number
    3009450884-2015-10038
    Event Type
    Injury
    Date Received
    May 14, 2015
    Date of Event
    April 24, 2015
    Report Date
    April 27, 2015
    Manufacturer
    SYNTHES GRENCHEN
    Product Code
    HWC
    PMA / PMN Number
    PK112583
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    A MANUFACTURING INVESTIGATION WAS PERFORMED: PLATE FRAGMENTS, TWO SCREW FRAGMENTS, AND 2 SCREWS WERE RECEIVED IN A SEALED BAG. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS LOT 7652157 OF 1.5MM TI T-PLATE 4 HOLES HEAD/8 HOLES SHAFT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS. TWO PIECES WERE SCRAPPED AT OPERATION 100 (LASER ETCH) FOR LASER ETCH ANOMALIES. THE LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE AND RELEASE. THERE IS NO INDICATION THAT THE LASER ETCH SCRAP PARTS HAD ANY INFLUENCE ON THE COMPLAINT CONDITION. NO OTHER ISSUES WERE DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE COMPONENT DEVICE HISTORY RECORD DETERMINED THE COMPONENT LOT, MET ALL SPECIFICATIONS. THERE ARE NO INDICATIONS OF ANY POTENTIAL ISSUES THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD DETERMINED THE RAW MATERIAL LOT WAS APPROVED WITH A DEVIATION BEING APPLIED TO THIS LOT. THE REDUCED BILLET LENGTH WAS APPROVED TO MITIGATE FLATNESS CONCERNS OF THE RAW MATERIAL. THE SHORTER BILLET LENGTH HAS NO IMPACT ON THE PRODUCT AND WOULD NOT CONTRIBUTE TO THE COMPLAINT CONDITION. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED, THEREFORE REVIEW TO THE SPECIFIC PRM AND PRM LINE IS NOT APPLICABLE. 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

    ADDITIONAL NARRATIVE: COMPLAINANT PART BROKE INTRA-OPERATIVELY AND WAS NOT IMPLANTED OR EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED. DEVICE HISTORY REVIEW: MANUFACTURING LOCATION: (B)(4) - MANUFACTURING DATE: AUGUST 7, 2014 - EXPIRY DATE: JULY 1, 2024 - NO NON-CONFORMANCE REPORTS 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 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 THE SURGEON TRIED TO FIX A PROXIMAL PHALANX FRACTURE OF THE MIDDLE FINGER WITH A PLATE. DURING SCREW INSERTION, THREE (3) SCREWS BROKE; THE SURGEON WAS NOT ABLE TO RETRIEVE THEM. THE SURGERY WAS COMPLETED WITH A DELAY OF AN UNKNOWN LENGTH OF TIME. THIS REPORT IS 3 OF 6 FOR (B)(4).

    Description of Event or Problem · 1

    THE PROCEDURE WAS PROLONGED FOR ABOUT THIRTY MINUTES. IT WAS REPORTED THAT TWO SCREWS AND A PLATE WERE BROKEN; THE REST OF THE SCREWS WERE INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315141 1.5MM TI CORTEX SCREW SELF-TAPPING 12MM SCREW, FIXATION, BONE HWC SYNTHES GRENCHEN 9090256

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention