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

Catalog Number	112230
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/22/2018
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
Pelvic array screw broke off.Surgical delay - =15 minutes.Case type: tha.
Event or Problem Description
Pelvic array screw broke off.Surgical delay =15 minutes.Case type: tha.
Additional Manufacturer Narrative
Reported event: pelvic array screw broke off.Surgical delay =15 minutes.Case type: tha.Product evaluation and results: visual inspection: visual inspection shows the thumb screw fractured and separated from the rest of the array assembly.There was apparent 'necking' in an area between the threads and tightening feature.Failure mode confirmed.Dimensional inspection: dimensional inspection was not completed since visual inspection confirmed the fractured 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: review of the product history records indicate 50 devices were manufactured under lot no 1945616 and accepted into final stock on 10/01/2016.No non-conformances were identified during inspection.Complaint history review: a review of complaints in trackwise related to p/n 112230, lot 19450616 shows 2 additional complaints related to the failure in this investigation.These prs are (b)(4).Conclusions: visual inspection confirmed the fractured 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.

• 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: 8020240
• Report Number: 3005985723-2018-00634
• Device Sequence Number: 1434738
• Product Code: OLO
• UDI-Device Identifier: 00848486002923
• UDI-Public: 00848486002923
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 01/03/2019

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: 19450616
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/22/2018
• Supplement Date Received by Manufacturer: 12/28/2018
• Initial Report FDA Received Date: 10/30/2018
• Supplement Report FDA Received Date: 01/03/2019
• 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