BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5MM TI T-PLATE 4 HOLES HEAD/ 8 HOLES SHAFT

    MDR report key: 4771830 · Received May 14, 2015

    Report

    Report Number
    3000270450-2015-10100
    Event Type
    Injury
    Date Received
    May 14, 2015
    Date of Event
    April 24, 2015
    Report Date
    April 27, 2015
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HRS
    PMA / PMN Number
    PPREAMEND
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS LOT 7652157, PART NUMBER 446.234 OF 1.5MM TI T-PLATE 4 HOLES HEAD / 8 HOLES SHAFT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NON-CONFORMANCES 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 THE BRANCH PLANT MATERIAL ISSUE LOT 7576842 MET ALL SPECIFICATIONS. A DEVIATION WAS APPLIED TO ALLOW SHORTER BILLET LENGTHS; THIS DEVIATION HAS NO EFFECT ON THE PRODUCT COMPLAINT AS THE MANUFACTURED PART PASSED ALL REQUIRED DIMENSIONAL AND COSMETIC REQUIREMENTS. THE DEVIATION WAS WRITTEN TO IMPROVE PRE-MANUFACTURE BILLET FLATNESS. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD DETERMINED LOT 7060382 WAS ISSUED PER APPROVED DEVIATION. 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 WHICH INCLUDED A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE (PART NUMBER 446.234, 1.5MM TI T-PLATE 4 HOLES HEAD/ 8 HOLES SHAFT, LOT 7652157). THE SUBJECT DEVICE WAS RECEIVED IN FRAGMENTS. 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 SCRAP AT OPERATION 100 (LASER ETCH) FOR LASER ETCH ANOMALIES. THIS 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 PART NUMBER 446SM031, BILLET 446SM031, LOT 7576842, RAW MATERIAL LOT 7060382 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 7060382 WAS APPROVED WITH DEVIATION ED357 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. 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: IT IS UNKNOWN IF THE COMPLAINANT PART WAS IMPLANTED DURING THE PROCEDURE. 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 PENDING COMPLETION. 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

    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.

    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 4 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316296 1.5MM TI T-PLATE 4 HOLES HEAD/ 8 HOLES SHAFT PLATE, FIXATION, BONE HRS SYNTHES SELZACH 9031621

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention