BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIP END EFFECTOR, VARIABLE ANGLE

    MDR report key: 7658620 · Received July 3, 2018

    Report

    Report Number
    3005985723-2018-00399
    Event Type
    Malfunction
    Date Received
    July 3, 2018
    Date of Event
    May 1, 2018
    Report Date
    July 12, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K121064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED TO UPDATE MANUFACTURER NAME, CITY AND STATE, MFR SITE, PMA/510K, IF FOLLOW-UP, WHAT TYPE AND DEVICE EVALUATED BY MFR BASED ON THE RESULTS OF INVESTIGATION. REPORTED EVENT: MICS WAS NOT WORKING, HAD TO REPLACE BEFORE REAMING, LATER IN THE CASE INLINE OFFSET IMPACTOR STUCK IN EE AFTER IMPACTION. THA PROCEDURE DELAYED A FEW MINUTES TO OPEN UP ANOTHER MICS; OTHERWISE, NO FURTHER DELAY FOR THE STUCK IMPACTOR. SURGICAL DELAY WAS ABOUT 5 MINUTES. DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION SHOWS THAT THE 202857 DOWEL PIN IS MISSING FROM THE SIDE NEXT TO THE SERIAL NUMBER. SEE ATTACHMENTS FOR IMAGES OF THE INSTRUMENT. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS NOT COMPLETED . FUNCTIONAL INSPECTION: FUNCTIONAL INSPECTION SHOWS THE DEVICE FUNCTIONS AS EXPECTED AND IS ABLE TO ACCEPT A KNOWN TO BE GOOD 209830 RIO SHELL IMPACT-OFFSET TRIDENT PST, BUT IT IS MISSING THE DOWEL PIN STATED ABOVE. MATERIAL ANALYSIS: MATERIAL ANALYSIS WAS COMPLETED AS PART OF THE ROOT CAUSE INVESTIGATION OF CAPA: 1450905. DEVICE HISTORY REVIEW: REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE 20 DEVICES WERE MANUFACTURED UNDER LOT NO: 19060214 AND ACCEPTED INTO FINAL STOCK ON 06/26/2014 . NO NON-CONFORMANCES WERE IDENTIFIED DURING INSPECTION. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N: 206967, LOT NUMBER: 19060214 SHOWS 05 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. THESE COMPLAINTS ARE: (B)(4). CONCLUSIONS: ALLEGED FAILURE CONFIRMED. SEE ATTACHED IMAGE. ROOT CAUSE CAN NOT BE DETERMINED. CORRECTIVE ACTION/PREVENTIVE ACTION: CAPA: 1450905 WAS INITIATED BASED ON OTHER COMPLAINTS REPORTING THIS ISSUE.

    Description of Event or Problem · 0

    MICS WAS NOT WORKING, HAD TO REPLACE BEFORE REAMING, LATER IN THE CASE INLINE OFFSET IMPACTOR STUCK IN EE AFTER IMPACTION. THA PROCEDURE DELAYED A FEW MINUTES TO OPEN UP ANOTHER MICS; OTHERWISE, NO FURTHER DELAY FOR THE STUCK IMPACTOR. SURGICAL DELAY WAS ABOUT 5 MINUTES. PER THE INVESTIGATION, A PIN WAS MISSING FROM THE HIP EE.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: MICS WAS NOT WORKING, HAD TO REPLACE BEFORE REAMING, LATER IN THE CASE INLINE OFFSET IMPACTOR STUCK IN EE AFTER IMPACTION. THA PROCEDURE DELAYED A FEW MINUTES TO OPEN UP ANOTHER MICS; OTHERWISE, NO FURTHER DELAY FOR THE STUCK IMPACTOR. SURGICAL DELAY WAS ABOUT 5 MINUTES. DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION- VISUAL INSPECTION SHOWS THAT THE 202857 DOWEL PIN IS MISSING FROM THE SIDE NEXT TO THE SERIAL NUMBER. SEE ATTACHMENTS FOR IMAGES OF THE INSTRUMENT. DIMENSIONAL INSPECTION- DIMENSIONAL INSPECTION WAS NOT COMPLETED . FUNCTIONAL INSPECTION- FUNCTIONAL INSPECTION SHOWS THE DEVICE FUNCTIONS AS EXPECTED AND IS ABLE TO ACCEPT A KNOWN TO BE GOOD 209830 RIO SHELL IMPACT-OFFSET TRIDENT PST, BUT IT IS MISSING THE DOWEL PIN STATED ABOVE. MATERIAL ANALYSIS- MATERIAL ANALYSIS WAS COMPLETED AS PART OF THE ROOT CAUSE INVESTIGATION OF CAPA (B)(4). DEVICE HISTORY REVIEW: REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE 20 DEVICES WERE MANUFACTURED UNDER LOT NO 19060214 AND ACCEPTED INTO FINAL STOCK ON 06/26/2014 . NO NON-CONFORMANCES WERE IDENTIFIED DURING INSPECTION. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N (B)(4), LOT NUMBER 19060214 SHOWS 05 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. THESE COMPLAINTS ARE: (B)(4). CONCLUSIONS: ALLEGED FAILURE CONFIRMED. SEE ATTACHED IMAGE. ROOT CAUSE CAN NOT BE DETERMINED. CORRECTIVE ACTION/PREVENTIVE ACTION: CAPA (B)(4) WAS INITIATED BASED ON OTHER COMPLAINTS REPORTING THIS ISSUE.

    Description of Event or Problem · 1

    MICS WAS NOT WORKING, HAD TO REPLACE BEFORE REAMING, LATER IN THE CASE INLINE OFFSET IMPACTOR STUCK IN EE AFTER IMPACTION. THA PROCEDURE DELAYED A FEW MINUTES TO OPEN UP ANOTHER MICS; OTHERWISE, NO FURTHER DELAY FOR THE STUCK IMPACTOR. SURGICAL DELAY WAS ABOUT 5 MINUTES. PER THE INVESTIGATION, A PIN WAS MISSING FROM THE HIP EE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503053 HIP END EFFECTOR, VARIABLE ANGLE STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. LOT 19060214 SN 1900368

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization