BEUDAMED
    FDA Adverse Event Other Summary report: N

    EASY EXPLANT BITS - 3.5 MM SS W/SZR PIN

    MDR report key: 4834244 · Received June 9, 2015

    Report

    Report Number
    9613350-2015-00652
    Event Type
    Other
    Date Received
    June 9, 2015
    Date of Event
    May 5, 2015
    Report Date
    June 26, 2015
    Manufacturer
    NORMED MEDIZIN-TECHNIK GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS WERE MADE AVAILABLE. NO TREND WAS IDENTIFIED. A SURGICAL REPORT WAS RECEIVED FOR REVIEW. THE REPORT DESCRIBES A WRIST JOINT SURGERY. IT IS MENTIONED THAT DURING REMOVING A DISTAL SCREW WITH THE INSTRUMENT, THE TIP OF THE BIT BROKE AND STAYED INTO THE SCREW. A SECOND SET WAS USED TO REMOVE ALL THE SCREWS, THE PLATE AND THE BROKEN BIT. THE INSTRUMENT WAS NOT RECEIVED FOR INVESTIGATION. POSSIBLE CAUSES FOR THE REPORTED EVENT ACCORDING TO SAP DFEMA: BROKEN BIT DUE TO: EXCESSIVE DETERIORATION OF INSTRUMENTS DURING LONG TERM USE; GENERAL CORROSION; CORROSION DUE TO RAW MATERIAL COMBINATIONS; IMPACTION FORCE ON THE INSTRUMENT DURING OPERATION; SURGEON OR OPERATING ROOM STAFF UNFAMILIAR WITH TECHNIQUE; DAMAGE OF INSTRUMENT THROUGH INCORRECT USE; OFF LABEL USE. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THIS ISSUE. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR REVIEW. AS NO LOT NUMBER WAS PROVIDED FOR THE DEVICE, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT. AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR REVIEW. AS NO LOT NUMBER WAS PROVIDED FOR THE DEVICE, THE DEVICE HISTORY COLD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT HAS NOW BEEN REPORTED THAT THE EASY EXPLANT BITS - 3.5 MM SS W/SZR PIN BROKE DURING SURGERY ON (B)(6) 2015.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A EASY EXPLANT BITS - 3.5 MM SS W/SZR PIN BROKE DURING SURGERY ON (B)(6) 2015, DURING POSITIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371441 EASY EXPLANT BITS - 3.5 MM SS W/SZR PIN EASY EXPLANT BIT HRS NORMED MEDIZIN-TECHNIK GMBH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR