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

Model Number	206967
Medical Device Problem Codes	Break (1069); Fracture (1260); Detachment of Device or Device Component (2907); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2019
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
Back end of the end effector broke off during reaming.Case type: tha.
Additional Manufacturer Narrative
It was reported that back end of the end effector broke off during reaming.Product evaluation and results: "visual inspection: visual inspection confirms failed locking mechanism.The 202866 release knob is missing.There is oxidation and discoloration on the 202870 slide assembly, 202862 ball retainer.The 206966 reamer barrell has fractures/cracks at the degree markers.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 1450905." product history review: review of the product history records indicate 47 devices were manufactured under lot 19540615 and (b)(4) devices were accepted into final stock on 10/19/2016.Review of qt 16-10-0052 revealed that (b)(4) devices were re inspected and 1 was accepted into final stock on 08/23/2019.It also revealed that the non conformance is not related to the failure alleged in this complaint.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 206967, lot 19540615 shows 10 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
Back end of the end effector broke off during reaming.Case type: tha.

• 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: 9327523
• Report Number: 3005985723-2019-00805
• Device Sequence Number: 19394098
• Product Code: OLO
• UDI-Device Identifier: 00848486022167
• UDI-Public: 00848486022167
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 01/21/2020

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
• Operator of Device: Health Professional
• Device Model Number: 206967
• Device Catalogue Number: 206967
• Device Lot Number: 1901187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Initial Date Received by Manufacturer: 10/23/2019
• Supplement Date Received by Manufacturer: 12/27/2019
• Initial Report FDA Received Date: 11/15/2019
• Supplement Report FDA Received Date: 01/21/2020
• 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