MAUDE Adverse Event Report: MAKO SURGICAL CORP. PELVIC ARRAY ASSY; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	112230
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/04/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Doctor (b)(6) was tightening the pelvic array onto the 2-dof clamp and the nut broke off of the pelvic array.Incision/exposure had not been done yet.All pieces were retrieved and taken off the field.We were able to proceed with a new pelvic array.Surgical delay=15 minutes.Case type: (b)(6).
Additional Manufacturer Narrative
Reported event: dr.(b)(6) was tightening the pelvic array onto the 2-dof clamp and the nut broke off of the pelvic array.Incision/exposure had not been done yet.All pieces were retrieved and taken off the field.We were able to proceed with a new pelvic array.Surgical delay- =15 minutes.Case type: tha.Product evaluation and results: visual inspection (see attachments): visual inspection shows the thumb screw fractured and is missing.Failure mode confirmed.Dimensional inspection dimensional inspection was not completed since visual inspection confirmed the missing thumb screw.Material analysis the material was confirmed during receiving inspection.Additional material analysis was not completed.Functional inspection functional inspection was not performed as the failure mode was confirmed during visual inspection.Product history review: a review of the device history records shows that 50 parts with this lot number were manufactured, inspected, and accepted into final stock with no non-conformances on december 3, 2014.Complaint history review: a review of complaints in trackwise related to p/n 112230, lot #19080814 shows 1 additional complaint related to the failure in this investigation.This pr is (b)(4).Conclusions: visual inspection confirmed the missing thumb screw.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.
Event or Problem Description
Dr.(b)(6) was tightening the pelvic array onto the 2-dof clamp and the nut broke off of the pelvic array.Incision/exposure had not been done yet.All pieces were retrieved and taken off the field.We were able to proceed with a new pelvic array.Surgical delay- =15 minutes.Case type: tha.

• Brand Name: PELVIC ARRAY ASSY
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8033032
• Report Number: 3005985723-2018-00644
• Device Sequence Number: 1584941
• Product Code: OLO
• UDI-Device Identifier: 00848486002923
• UDI-Public: 00848486002923
• 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): 01/15/2019

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: 112230
• Device Lot Number: 19080814
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/04/2018
• Supplement Date Received by Manufacturer: 01/08/2019
• Initial Report FDA Received Date: 11/02/2018
• Supplement Report FDA Received Date: 01/15/2019
• 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