MAUDE Adverse Event Report: MAKO SURGICAL CORP. HIP END EFFECTOR, VARIABLE ANGLE; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	206967
Medical Device Problem Codes	Crack (1135); Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/25/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Hip end effector was damaged while surgeon was impacting cup.Impactor plate and inline offset impactor were damaged as well.I had a replacement set of instruments to open onto the sterile field.Surgeon had difficulty removing broken instruments off of the robot, which added to the delay in surgery.Case type: tha.Surgical delay: 35 minutes.This complaint is for the 206967 hip end effector, variable angle.Associated complaints from the same surgery include: (b)(4).
Additional Manufacturer Narrative
Follow-up #1 and final report submitted to update sections mfr name, city & state, mfr site, premarket identification, type of report, follow up type, device evaluated by mfr, adverse event problem, additional mfr narrative based on the results of investigation.It was reported that hip end effector was damaged while surgeon was impacting cup.Impactor plate and inline offset impactor were damaged as well.I had a replacement set of instruments to open onto the sterile field.Surgeon had difficulty removing broken instruments off of the robot, which added to the delay in surgery.Case type: tha.Surgical delay: 35 minutes.Product evaluation and results: visual inspection.Visual inspection detected marks on the 202866 knob.The 206966 reamer barrell has fractures/cracks at the degree markers.See attachments for images of the instrument.Dimensional inspection: dimensional inspection was not completed as visual inspection clearly shows the failure of the device.Functional inspection: functional inspection as not completed as visual inspection clearly shows the failure of the device.Material analysis: material analysis was completed as part of the root cause investigation of capa product history review: review of the product history records for lot 19231118 indicates 150 devices were manufactured and (b)(4) devices were accepted into final stock on (b)(6) 2019.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 206967, lot 19231118 shows 4 additional complaints related to the failure in this investigation.Conclusions: the failure is confirmed via visual inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.
Event or Problem Description
Hip end effector was damaged while surgeon was impacting cup.Impactor plate and inline offset impactor were damaged as well.I had a replacement set of instruments to open onto the sterile field.Surgeon had difficulty removing broken instruments off of the robot, which added to the delay in surgery.Case type: tha.Surgical delay: 35 minutes.This complaint is for the 206967 hip end effector, variable angle.Associated complaints from the same surgery include: (b)(4).

• Brand Name: HIP END EFFECTOR, VARIABLE ANGLE
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9147809
• Report Number: 3005985723-2019-00714
• Device Sequence Number: 11404997
• Product Code: OLO
• UDI-Device Identifier: 00848486022167
• UDI-Public: 00848486022167
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K121064
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 206967
• Device Lot Number: 19231118 / 1904450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2019
• Initial Date Received by Manufacturer: 09/25/2019
• Supplement Date Received by Manufacturer: 11/26/2019
• Initial Report FDA Received Date: 10/02/2019
• Supplement Report FDA Received Date: 12/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization