MAUDE Adverse Event Report: MAKO SURGICAL CORP. CUTTER POWER INPUT DELIVERY ASSEMBLY 3.0; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 209954

Device Problems Electrical /Electronic Property Problem (1198); Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/09/2018

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

(b)(4) mps (b)(6) reported loss of power in two mics during surgery.Update: product not returned due to error with robot not mics rob 567 case type? tka.Was there patient involvement? any patient harm? state any adverse consequences.No patient harm, just slower cuts and longer tourniquet time any surgical delay? <30 min due to changing of mics 1 to mics 2.

Manufacturer Narrative

Follow-up #1 and final report submitted.Reported event: two mics handpieces reported loss of power during tka procedure.Device inspection: per gsp case #: (b)(4).Mps noticed a loss of power in two mics handpieces during surgery.These did not pass mics status check.Replaced cutter input delivery assembly 209954.System successfully passed all validation testing.System was verified to be operating within mako tolerances and specifications.System is ready for clinical use.Device history review: a review of the dhr associated with rob567 found qips passed with no notes or comments.Complaint history: a review of complaints in catsweb and trackwise related to the cutter power input delivery assembly 3.0, catalog #: 209954, lot number #: 507954 shows no additional complaints related to the failure in this investigation.Conclusion: per fse: the cutter power input delivery assembly 3.0 was replaced.The system successfully passed all validation testing and is operating within mako tolerances and specifications.The system is ready for clinical use.Further action: none at this time.

Event Description

(b)(4): mps daniel collaco reported loss of power in two mics during surgery.Update: product not returned due to error with robot not mics rob 567.Case type? tka.Was there patient involvement? any patient harm? state any adverse consequences.No patient harm, just slower cuts and longer tourniquet time.Any surgical delay? <30 min due to changing of mics 1 to mics 2.

• Brand Name: CUTTER POWER INPUT DELIVERY ASSEMBLY 3.0
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 7377414
• MDR Text Key: 104137155
• Report Number: 3005985723-2018-00199
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K170581
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 209954
• Device Lot Number: LOT: 507954
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/09/2018
• Initial Date FDA Received: 03/28/2018
• Supplement Dates Manufacturer Received: 04/30/2018
• Supplement Dates FDA Received: 05/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization