BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL TITANIUM PROSTHESIS

    MDR report key: 4427428 · Received January 16, 2015

    Report

    Report Number
    1045254-2015-00017
    Event Type
    Injury
    Date Received
    January 16, 2015
    Date of Event
    December 15, 2014
    Report Date
    December 22, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETA
    PMA / PMN Number
    K002897
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT CLARIFIED THE EVENT. THE IMPLANTED PROSTHESIS BROKE DURING REMOVAL OF THE DEVICE; THE SECOND PROSTHESIS DID NOT BREAK. FOR 0208316361 EXPIRATION DATE: 05/2022, 05/2014.

    Additional Manufacturer Narrative · 1

    BLANK FIELDS IN THIS REPORT ARE THE RESULT OF INFORMATION NOT PROVIDED BY THE INITIAL REPORTER OR USER FACILITY. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE DEVICE WAS RECEIVED AND EVALUATED. AS RECEIVED CONDITION: RECEIVED 1 SAMPLE(S), PART NUMBER 1150001, FROM LOT NUMBER [NOT PROVIDED]; THERE WAS EVIDENCE OF BIOLOGICAL CONTAMINANTS [BASED OFF OF THE REACTIVITY WITH HYDROGEN PEROXIDE]. NOTE: THE REPORTED PART NUMBER WAS 1150000 AND THE SHAPE AND SIZE OF THE RETURNED SAMPLE INDICATES THE PART NUMBER IS ACTUALLY 1150001; THE LOT NUMBER 0208316321 IS NOT VALID FOR THE REPORTED PART; THE RETURNED SAMPLE ¿LABELING¿ IS NOT CONSISTENT WITH THE RETURNED SAMPLE. EQUIPMENT USED: MICROSCOPE (ZEISS STEMI 2000C BETWEEN 0, 65 TO 5, 0 MAGNIFICATION SETTINGS), CALIPERS. OBSERVATIONS: WHEN COMPARED TO THE ASSEMBLY DRAWING: A BREAK POINT OCCURRED IN THE BELL MOUNTING AREA OF THE FLEX H/A [PART CP070092] WHICH WOULD HAVE RESULTED IN THE REPORTED MALFUNCTION. THE HEAD OF THE PROSTHESIS WAS BENT WHICH IS AN INDICATOR THAT THE DEVICE WAS MISHANDLED. THE TITANIUM BELL SHOWED SIGNS OF A RESIDUE CONSISTENT WITH ADHESIVE [PART 60D1141] INDICATING THAT THE FLEX H/A WAS ATTACHED AT SOME POINT TO THE BELL AND IT WAS ASSEMBLED PER THE DRAWING; MANUFACTURING HAS BEEN RULED OUT AS A POTENTIAL CAUSE. NOTE: A PORTION OF THE FLEX H/A WAS STILL ATTACHED TO THE SHAFT AND WAS REMOVED FOR FURTHER ANALYSIS. THE SHAFT CONFIGURATION AT THE END IS CONSISTENT WITH IT BEING TRIMMED. THE OVERALL LENGTH OF THE HEAD/SHAFT ASSEMBLY INDICATES A ¿REFERENCE¿ OVERALL LENGTH OF 0.400 INCH [10.16MM] AND THE ACTUAL MEASUREMENT WAS 0.09¿. THE INFORMATION INDICATES THE DEVICE WAS MODIFIED. THERE WERE NO SIGNS THAT THE DEVICE WAS CLOSED IN THE LID OF THE CAPSULE AND THERE WAS NO DAMAGE TO THE PACKAGING / CAPSULE. THE H/A SIDE WHERE THE BREAK OCCURRED WAS JAGGED WHICH INDICATES IT WAS PULLED APART. THERE WAS NO EVIDENCE OF IMPROPER MANUFACTURING; THEREFORE, HAS BEEN RULED OUT AS A POTENTIAL CAUSE. BASED ON THE ABOVE OBSERVATIONS THE UNDERLYING CAUSE IS CONSISTENT WITH, MISHANDLING. METHODS: MICROSCOPIC INSPECTION FDA. RESULTS: FRACTURE PROBLEM FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ¿THE PATIENT COMPLAINED THAT THE HEARING DIDN¿T GET IMPROVED AFTER THE IMPLANT, SO THE DOCTOR DECIDED TO DO SECOND SURGERY. THE DOCTOR PLANNED TO TAKE OUT THE PROSTHESIS AND IMPLANT IT LATER. HOWEVER, DURING THE PROCEDURE, THE TITANIUM PART OF THE SHOE DETACHED FROM THE WHITE PART OF THE SHOE. THE DOCTOR SPENT ABOUT 20 MINUTES TAKING OUT THE FRAGMENTS OF NEW PROSTHESIS AND OPENED ANOTHER NEW PROSTHESIS TO COMPLETE THE SURGERY. AS A RESULT, THE OPERATION WAS DELAYED FOR 20 MINUTES.¿

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT CLARIFIED THE EVENT. THE IMPLANTED PROSTHESIS BROKE DURING REMOVAL OF THE DEVICE; THE SECOND PROSTHESIS DID NOT BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42093 UNIVERSAL TITANIUM PROSTHESIS REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL ETA MEDTRONIC XOMED INC. 1150000 0208316361

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention