MAUDE Adverse Event Report: MAKO SURGICAL CORP. BRAKE, DOUBLE DISC, 100 NM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 204708

Device Problems Fluid/Blood Leak (1250); Mechanical Problem (1384)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 02/06/2020

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

Case number: (b)(4) - mps reported hydraulic fluid leak and brake check failing.Case type : case type : tka.

Manufacturer Narrative

Update to d2.Reported event: it was reported that rob203 - mps reported hydraulic fluid leak and brake check failing.Case type : case type : tka.Product evaluation and results: as per work order: dissassembled j6 brake assembly and re-surfaced and cleaned.Re-assembled and tested per service manual.Calibrated as necessary.Successfully completed transmission, friction, and auto arm-accuracy, and pre-surgery tests per service manual requirements.Checked fittings on hydraulic pump assy and tightened to eliminate any oil drips.Asked mps to monitor.System is ready for clinical use.System investigation completed successfully as per service manual.All system checks and tests passed, system is ready for use.Product history review: cannot be performed as the lot/ serial is not reported.Complaint history review: cannot be performed as the lot/ serial is not reported.Conclusion: per, preventive maintenance is where an action occurs that identifies device deterioration which may compromise function.Under pm conditions no patient was involved and no actual or potential patient harm existed for the alleged event.The failure is confirmed via inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.

Event Description

Case number: (b)(4), (b)(6) - mps reported hydraulic fluid leak and brake check failing.Case type: case type: tka.

• Brand Name: BRAKE, DOUBLE DISC, 100 NM
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9780158
• MDR Text Key: 189648580
• Report Number: 3005985723-2020-00128
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K112507
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 204708
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other