BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE PIN, 3.2MM X 140MM, STERILE 2 PACK

    MDR report key: 9757994 · Received February 26, 2020

    Report

    Report Number
    3005985723-2020-00106
    Event Type
    Malfunction
    Date Received
    February 26, 2020
    Date of Event
    January 30, 2020
    Report Date
    May 14, 2020
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    07613327412376
    PMA / PMN Number
    K112507
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED ISSUE- SURGEON BEGAN PLACING PIN IN HIP FOR ARRAY PLACEMENT (NON OPERATIVE HIP FOR DA APPROACH). SURGEONS STATED HE BARELY BROKE BIN WHEN THE TIP BROKE OFF. PATIENT WAS X-RAYED AND TIP OF PIN WAS REMOVED FROM THE BONE. PRODUCT INSPECTION - AS PER THE IMAGE PROVIDED IN THE COMMUNICATION LOG , THE BROKEN PIN CAN BE SEEN AND CONFIRMED. ALSO THE DEVICE HAS BEEN DISCARDED BY THE HOSPITAL. PRODUCT HISTORY REVIEW ¿ REVIEW OF THE DEVICE HISTORY RECORDS INDICATE (B)(4) WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 03/05/2019. NO NON-CONFORMANCES WERE IDENTIFIED DURING INSPECTION. COMPLAINT HISTORY REVIEW - A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 213527, LOT 48100219 SHOWS NO ADDITIONAL COMPLAINT RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSION ¿ THE FAILURE IS CONFIRMED VIA VISUAL INSPECTION OF THE IMAGE PROVIDED IN THE COMMUNICATION LOG. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED THEN THE COMPLAINT WILL BE REOPENED. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    SURGEON BEGAN PLACING PIN IN HIP FOR ARRAY PLACEMENT (NON OPERATIVE HIP FOR DA APPROACH). SURGEONS STATED HE BARELY BROKE BIN WHEN THE TIP BROKE OFF. PATIENT WAS X-RAYED AND TIP OF PIN WAS REMOVED FROM THE BONE. CASE TYPE: THA.

    Additional Manufacturer Narrative · 1

    AS PART OF THE 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.

    Description of Event or Problem · 1

    SURGEON BEGAN PLACING PIN IN HIP FOR ARRAY PLACEMENT (NON OPERATIVE HIP FOR DA APPROACH). SURGEONS STATED HE BARELY BROKE BIN WHEN THE TIP BROKE OFF. PATIENT WAS X-RAYED AND TIP OF PIN WAS REMOVED FROM THE BONE. CASE TYPE: THA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218022 BONE PIN, 3.2MM X 140MM, STERILE 2 PACK ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAKO SURGICAL CORP. 213527 48100219 07613327412376

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other