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

Model Number	206967
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/05/2019
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
Stub on bottom of tha end effector array came off after removal from mako arm (after case).Case type: tha.
Additional Manufacturer Narrative
Reported event: it was reported that stub on bottom of tha end effector array came off after removal from mako arm (after case).Product evaluation and results: visual inspection: visual inspection confirms failed locking mechanism.There is oxidation and discoloration on the 202870 slide assembly, 202862 ball retainer.The 202857 dowel pin that locates the 202870 slide assembly has backed out, causing the slide assembly to rotate freely.The 202866 release knob is sheared off.The 111777 locating pin is missing.The 202866 knob and the base have dent marks.The degree markers bears crack/ fracture.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 1450905.Product history review: review of the device history records indicate (b)(4) devices were manufactured and (b)(4) accepted into final stock on 11/28/2016.Review of qt 16-11-0080 revealed that (b)(4) devices were accepted into final stock on 08/23/2019.The non conformance is not related the failure alleged in this complaint.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 206967, lot number 19530615 shows 5 additional complaints related to the failure in this investigation.The complaints are (b)(4).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.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there have been an nc and capa associated with the product and failure mode reported in this event.This is nc (b)(4) & capa 1450905.
Event or Problem Description
Stub on bottom of tha end effector array came off after removal from mako arm (after case).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: 9396699
• Report Number: 3005985723-2019-00867
• Device Sequence Number: 11187304
• Product Code: OLO
• UDI-Device Identifier: 00848486022167
• UDI-Public: 00848486022167
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 01/30/2020

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: 19530615/1901415
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 01/30/2020
• 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