BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAR RADIUS FRACTURE PLATE, LOCKING, MEDIUM, LONG

    MDR report key: 4062421 · Received September 5, 2014

    Report

    Report Number
    0008010177-2014-00236
    Event Type
    Injury
    Date Received
    September 5, 2014
    Date of Event
    January 7, 2014
    Report Date
    August 8, 2014
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S. ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF THE MATRIX PLATE ¿ POSTOPERATIVE BREAKAGE COULD BE CONFIRMED. THE MACROSCOPIC AND MICROSCOPIC INVESTIGATION REVEALED THAT THE PLATE BROKE IN LOW CYCLE FATIGUE MODE BY EXCEEDING THE MATERIAL STRENGTH AFTER A FEW CYCLES UNDER PARTIALLY VERY HIGH FORCES. THE SEM EXAMINATION SHOWS AT THE FRACTURE SURFACES THE APPEARANCE OF A LOW CYCLE FATIGUE RUPTURE. MUCH EVIDENCE OF FORCED RUPTURE AND SECONDARY CRACKS ALSO EXISTS. IN ADDITION SWINGING LINES OF A FATIGUE BREAKAGE ARE VISIBLE TO SOME EXTENT. THE ROOT CAUSE OF THE FAILURE COULD BE A POWERFUL DYNAMICALLY OVERLOAD OF THE FRACTURE, E.G. BECAUSE THE PATIENT FELL OR SUPPORTED HIMSELF UNILATERAL WITH HIS HAND. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. INDICATIONS FOR MATERIAL OR MANUFACTURING RELATED PROBLEMS WERE NOT FOUND IN THIS INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED, A VOLAR LOCKING PLATE WITH REFERENCE NUMBER 54-25281S, IMPLANTED ON (B)(6) 2014, WAS FOUND TO BE BROKEN. PATIENT WAS REVISED TO A VOLAR LOCKING PLATE ON (B)(6) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED, A VOLAR LOCKING PLATE WITH REFERENCE NUMBER (B)(4), IMPLANTED ON (B)(6) 2014, WAS FOUND TO BE BROKEN. PATIENT WAS REVISED TO A VOLAR LOCKING PLATE ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545369 PALMAR RADIUS FRACTURE PLATE, LOCKING, MEDIUM, LONG IMPLANT HRS STRYKER LEIBINGER FREIBURG 1000094950

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention