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

Catalog Number	112230
Medical Device Problem Codes	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	07/26/2018
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
Broken screw pelvic array.The set is heavily used and the surgeon uses a lot of force tightening the screw.Another pelvic array was available to complete the case.
Event or Problem Description
Broken screw pelvic array.The set is heavily used and the surgeon uses a lot of force tightening the screw.Another pelvic array was available to complete the case.
Additional Manufacturer Narrative
Reported event: broken screw pelvic array.The set is heavily used and the surgeon uses a lot of force tightening the screw.Another pelvic array was available to complete the case product evaluation and results: visual inspection.Visual inspection shows thumb screw damage.See attachment 1 for image of the instrument.Dimensional inspection: dimensional inspection was not completed since visual and functional inspection confirmed damaged thumb screw.Functional inspection: functional inspection confirmed pelvic array assembly, p/n 112230 damaged thumb screw not engaging properly.Product history review: review of the device history records indicate (b)(4) were manufactured under lot 19470117 and accepted into final stock on 04/07/2017.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 112230, lot number 19470117 shows no additional complaints related to the failure in this investigation.Conclusions: visual inspection confirmed damaged thumb screw.Functional inspection confirmed thumb screw not engaging onto array adapter.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: 7754404
• Report Number: 3005985723-2018-00459
• Device Sequence Number: 11240501
• Product Code: OLO
• UDI-Device Identifier: 00848486002923
• UDI-Public: 00848486002923
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 10/09/2018

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: 112230LOT 19470117
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/26/2018
• Supplement Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 08/06/2018
• Supplement Report FDA Received Date: 10/09/2018
• 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