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

Catalog Number	206967
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/16/2019
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
End effector collar broke off.Case type: tha.Patient was under anesthesia.
Additional Manufacturer Narrative
It was reported that end effector collar broke off.Product evaluation and results: visual inspection.Visual inspection confirms failed locking mechanism.A ring can be seen on the back of the 202866 release knob.The 202866 release knob is sheared off.There is oxidation and discoloration on the 202870 slide assembly, 202862 ball retainer.The 206966 reamer barrel has fractures/cracks at the degree markers.There are damaged marks on the base of the end effector.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 device history records indicate (b)(4) were manufactured under lot 19410515 and 38 accepted into final stock on 08/30/2016.Review of qt16-08-0108 revealed that the non-conformance is not related to the failure alleged in this compliant." complaint history review: a review of complaints in catsweb and trackwise related to p/n 206967, lot number 19410515 shows 18 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
End effector collar broke off.Case type: tha.Patient was under anesthesia.

• 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: 9362260
• Report Number: 3005985723-2019-00837
• Device Sequence Number: 19374830
• Product Code: OLO
• UDI-Device Identifier: 00848486022167
• UDI-Public: 00848486022167
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 12/19/2019

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 Catalogue Number: 206967
• Device Lot Number: 19410515/ 1901070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Initial Date Received by Manufacturer: 09/16/2019
• Supplement Date Received by Manufacturer: 11/23/2019
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 12/19/2019
• 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