BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL, TRI-FLAT T2 FEMUR Ø4,2X340 MM

    MDR report key: 5177175 · Received October 26, 2015

    Report

    Report Number
    0009610622-2015-00502
    Event Type
    Malfunction
    Date Received
    October 26, 2015
    Date of Event
    September 29, 2015
    Report Date
    October 7, 2015
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    PRODUCT INQUIRY STATES THE DRILL TO BE THE SUBJECT PRODUCT. NO FURTHER ASSOCIATED PRODUCTS WERE REPORTED. THE REVIEW OF THE INSPECTION RECORDS REVEALED NO DISCREPANCIES. RELEVANT DIAMETERS AND MECHANICAL PROPERTIES ARE WITHIN SPECIFIED PARAMETERS. THUS, WE EXCLUDE DEVIATIONS IN MATERIAL AND MANUFACTURING. ACCORDING TO THE APPEARANCE OF THE BREAKAGE SURFACES, THE DRILL BROKE IN A (FORCED) BRITTLE MANNER DUE TO OVERLOAD, MOST LIKELY BY BENDING STRESSES. THE BREAKAGE MAY BE CAUSED BY DRILLING UNDER MISALIGNMENT AND / OR CONTACT WITH A HARD OBJECT. ACCORDING TO INFORMATION RECEIVED ¿PROBABLY THE DRILL HIT THE PEG OF THE DE-PUY S¿. AS THE DRILL HAD BEEN IN USE FOR A LONGER TIME (MANUFACTURED IN 2011) WE PRE-SUPPOSE THAT THE DEVICE HAD FULFILLED ITS TASKS IN FORMER SURGERIES AS INTENDED AND HAS TO BE REPLACED AS STATED IN ¿INSTRUCTIONS FOR CLEANING, STERILIZATION, INSPECTION AND MAINTENANCE¿. BASED ON THE ABOVE FACTS THE ROOT CAUSE OF THE REPORTED EVENT IS NOT RELATED TO A DEFICIENCY OF THE DEVICE, BUT IS RATHER LINKED TO IMPROPER HANDLING BY THE USER. NO NON-CONFORMITY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRILL WAS BROKEN DURING MEDICAP PROCEDURE. THE TIP OF THE DRILL WAS REMAINED IN THE DISTAL FEMUR. TKA IMPLANT IS DE-PUY. PROBABLY THE DRILL HIT THE PEG OF THE DE-PUY. THE SURGEON IS WORRIED ABOUT CORROSION AND HEATING DUE TO CONTACT WITH TKA IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRILL WAS BROKEN DURING MEDICAP PROCEDURE. THE TIP OF THE DRILL WAS REMAINED IN THE DISTAL FEMUR. TKA IMPLANT IS DE-PUY. PROBABLY THE DRILL HIT THE PEG OF THE DE-PUY. THE SURGEON IS WORRIED ABOUT CORROSION AND HEATING DUE TO CONTACT WITH TKA IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708966 DRILL, TRI-FLAT T2 FEMUR Ø4,2X340 MM SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHMENTS HWE STRYKER TRAUMA KIEL K271935

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other