BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAMP ASSEMBLY- 3-PIN

    MDR report key: 6630619 · Received June 9, 2017

    Report

    Report Number
    3005985723-2017-00245
    Event Type
    Malfunction
    Date Received
    June 9, 2017
    Date of Event
    June 6, 2017
    Report Date
    July 27, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K141989
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED BY MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: AN EVENT REGARDING A BROKEN 110716 CLAMP ASSEMBLY- 3-PIN WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: A COMPLETE EVALUATION OF THE PART COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT AVAILABLE FOR EVALUATION. DEVICE HISTORY REVIEW: A REVIEW OF THE DEVICE HISTORY RECORDS SHOWS THAT 16 PARTS WERE MANUFACTURED, INSPECTED, AND ACCEPTED INTO FINAL STOCK ON 6/4/2012. COMPLAINT HISTORY REVIEW: BASED ON THE DEVICE IDENTIFICATION, THE CATSWEB AND TRACKWISE COMPLAINT DATABASES WERE REVIEWED FOR SIMILAR REPORTED EVENTS REGARDING A 110716 PELVIC ARRAY ASSY NOT FUNCTIONING. THERE HAS BEEN 5 OTHER COMPLAINTS FOR THE REFERENCED LOT NUMBER. THE COMPLAINTS ARE PR# (B)(4), AND (B)(4) AND CATSWEB ISSUE #'S 211, 2528, & 4426. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT WAS NOT CONFIRMED BECAUSE THE PART WAS NOT AVAILABLE FOR EVALUATION. CORRECTIVE ACTION/PREVENTIVE ACTION: NO FURTHER ACTION NEEDS TO BE TAKEN. THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE BACK SCREW THAT TIGHTENS THE 3 PIN CLAMP BROKE OFF WHILE THE SURGEON WAS TAKING THE CLAMP OFF OF THE PINS. TYPE OF CASE: THA.

    Description of Event or Problem · 1

    THE BACK SCREW THAT TIGHTENS THE 3 PIN CLAMP BROKE OFF WHILE THE SURGEON WAS TAKING THE CLAMP OFF OF THE PINS. TYPE OF CASE: THA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412799 CLAMP ASSEMBLY- 3-PIN STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 06120512

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization