BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    MDR report key: 3070911 · Received April 22, 2013

    Report

    Report Number
    2530088-2013-10493
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    August 3, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HTJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE VISUAL INSPECTION DONE AS PART OF THE PRODUCT EVALUATION REVEALED THE TIP WAS BROKEN OFF WHERE THE NEEDLE THREADS INTO THE SLIDERS. THE NEEDLE WAS NOT RETURNED. THE FRACTURE FACE IS HOMOGENOUS WHICH INDICATES MATERIAL UNIFORMITY. THERE ARE LONGITUDINAL SURFACE MARKS ON THE SLIDER WHICH ARE CONSISTENT WITH FIELD USE. ALL COMPONENTS OF THE DEVICE WERE PRESENT EXCEPT THE NEEDLE AS PREVIOUSLY NOTED AND THE PROTECTION SLEEVE WAS NOT RETURNED. THE RETURNED DEVICE WAS MANUFACTURED IN AUGUST 2005 AND IS OVER 6 YEARS OLD AND SHOWS EVIDENCE OF EXTENSIVE USE. TO FURTHER REDUCE THE RISK OF ACCIDENTAL BREAKAGE, A PROTECTIVE SLEEVE IS INCLUDED WITH THE DEVICE THAT THREADS ONTO THE SLIDER AND PROTECTS THE NEEDLE WHEN NOT IN USE. THE SLEEVE WAS NOT RETURNED WITH THIS INSTRUMENT AND IT CANNOT BE DETERMINED IF IT WAS USED AS RECOMMENDED. IT IS CONCLUDED THAT THE DESIGN IS ADEQUATE FOR THE INTENDED USE, THERE IS NOTHING TO INDICATE A DESIGN ISSUE AND THIS COMPLAINT IS INVALID.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ADDITIONAL NARRATIVE: THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED EVENT.

    Description of Event or Problem · 1

    HOSPITAL REPORTED TO CONSULTANT THE NEEDLE PART OF THE DEPTH GAUGE BROKE OFF THE HANDLE. IT IS NOT KNOWN WHEN OR HOW THE INSTRUMENT BROKE. THIS IS REPORT 1 OF 1 FOR THIS EVENT, COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172745 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS HTJ SYNTHES BRANDYWINE 5069139

    Patients

    Seq Age Sex Outcome Treatment
    1