BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL, AO T2 FEMUR 4,2X340 MM

    MDR report key: 9891479 · Received March 27, 2020

    Report

    Report Number
    0009610622-2020-00131
    Event Type
    Malfunction
    Date Received
    March 27, 2020
    Date of Event
    March 3, 2020
    Report Date
    August 26, 2020
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    UDI-DI
    04546540196767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO THE CURRENT COVID-19 PANDEMIC IT WAS NOT POSSIBLE TO INSPECT THE PRODUCT AS THE ACCESS TO THE FACILITY IS RESTRICTED. THE INVESTIGATION WILL BE REASSESSED AS SOON AS RESTRICTION IS LIFTED. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD BE CONFIRMED, SINCE THE DEVICE WAS RETURNED FOR EVALUATION AND MATCHES THE ALLEGED FAILURE MODE. THE DEVICE INSPECTION REVEALED THE FOLLOWING: THE RECEIVED DRILL WAS FOUND TO BE BROKEN FROM THE FLUTE AREA. FLUTES APPEAR TO BE RATHER ALRIGHT AS OPPOSED TO GENERALLY OBSERVED DEFORMATION AND DAMAGES AFTER LONG AND PROLONGED USAGE. THE BREAKAGE SURFACE REVEALS A RELATIVELY SMOOTHER SURFACE AT THE CENTRE THAN TOWARDS THE EDGES, AS ALSO CONFIRMED BY THE DISTAL SEGMENT OF THE DRILL. THIS CONFIRMS A TYPICAL BRITTLE FRACTURE OF THE DRILL DUE TO TORSIONAL AND BENDING OVERLOAD. AS PER THE HARDNESS TESTING, THE RETURNED DRILL WAS FOUND TO HAVE AN AVERAGE HARDNESS OF 53.6 HRC AGAINST A REQUIRED RANGE OF 52.0 TO 56.0 HRC. THEREFORE, IT WAS FOUND TO BE WELL WITHIN SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. REFERRING TO THE VERY LONG PERIOD SINCE MANUFACTURING [MANUFACTURED IN 2010] IT IS SAFE TO SAY THE DEVICE HAS REACHED THE END OF ITS USEFUL SERVICE-LIFE AND HAD FULFILLED ITS TASKS IN FORMER SURGERIES AS INTENDED, UNTIL THE REPORTED EVENT, WITHOUT PROBLEMS REPORTED. NO INDICATIONS OF MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. BASED ON THE INVESTIGATION THE ROOT CAUSE WAS ATTRIBUTED TO A USER RELATED ISSUE. THE BREAKAGE OF THE DRILL HAPPENED DUE TO COMBINED TORSIONAL AND BENDING OVERLOAD DURING THE SURGERY RESULTING IN A BRITTLE FRACTURE, EVIDENT BY THE BREAKAGE SURFACE UNDER SUCH A SITUATION, THE DRILL ENCOUNTERS A LOT OF STRESS (ALONG WITH THE RESIDUAL STRESS OVER A LONG PERIOD OF USE) WHICH LEADS TO A SUDDEN BREAKAGE (BRITTLE), AS IN THIS CASE. IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Description of Event or Problem · 0

    PHARMACIST, REPORTED BY PHONE: "THE DRILL BROKE DURING THE PROCEDURE. THERE WAS A PROCEDURE DELAY. NO FURTHER INFORMATION AVAILABLE, WE WILL PROVIDE YOU MORE DETAILS". ADDITIONALLY REPORTED BY PHARMACIST: "I CONFIRM MATERIOVIGILANCE NOTIFICATION ON PRODUCT 18064260 LOT K227443. THE EVENT HAPPENED DURING PROCEDURE, WHEN INSERTING THE DRILL BIT INTO THE LOCKING HOLE OF THE NAIL. THERE WERE NO CONSEQUENCES ON THE PROCEDURE TIME (REPLACEMENT OF THE DRILL WITH ANOTHER AVAILABLE DRILL) OR ON THE PATIENT (EASY REMOVAL OF THE 2 PIECES). NO MEDICAL INTERVENTION WAS NECESSARY."

    Description of Event or Problem · 0

    PHARMACIST, REPORTED BY PHONE: "THE DRILL BROKE DURING THE PROCEDURE. THERE WAS A PROCEDURE DELAY. NO FURTHER INFORMATION AVAILABLE, WE WILL PROVIDE YOU MORE DETAILS". ADDITIONALLY REPORTED BY PHARMACIST: "I CONFIRM MATERIOVIGILANCE NOTIFICATION ON PRODUCT 18064260 LOT K227443. THE EVENT HAPPENED DURING PROCEDURE, WHEN INSERTING THE DRILL BIT INTO THE LOCKING HOLE OF THE NAIL. THERE WERE NO CONSEQUENCES ON THE PROCEDURE TIME (REPLACEMENT OF THE DRILL WITH ANOTHER AVAILABLE DRILL) OR ON THE PATIENT (EASY REMOVAL OF THE 2 PIECES). NO MEDICAL INTERVENTION WAS NECESSARY."

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF INVESTIGATION, ADDITIONAL INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PHARMACIST, REPORTED BY PHONE: "THE DRILL BROKE DURING THE PROCEDURE. THERE WAS A PROCEDURE DELAY. NO FURTHER INFORMATION AVAILABLE, WE WILL PROVIDE YOU MORE DETAILS". ADDITIONALLY REPORTED BY PHARMACIST: "I CONFIRM MATERIOVIGILANCE NOTIFICATION ON PRODUCT 18064260, LOT K227443. THE EVENT HAPPENED DURING PROCEDURE, WHEN INSERTING THE DRILL BIT INTO THE LOCKING HOLE OF THE NAIL. THERE WERE NO CONSEQUENCES ON THE PROCEDURE TIME (REPLACEMENT OF THE DRILL WITH ANOTHER AVAILABLE DRILL) OR ON THE PATIENT (EASY REMOVAL OF THE 2 PIECES). NO MEDICAL INTERVENTION WAS NECESSARY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355843 DRILL, AO T2 FEMUR 4,2X340 MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA KIEL 1806-4260 K227443 04546540196767

    Patients

    Seq Age Sex Outcome Treatment
    1