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

Catalog Number	112230
Medical Device Problem Codes	Break (1069); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/02/2019
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
Tha.Event description: the screw that tightens the pelvic array to the pelvic array clamp broke.Surgical delay 4 minutes.
Additional Manufacturer Narrative
Reported event: it was reported that the pelvic array screw broke during assembly.Product evaluation and results: visual inspection: visual inspection confirms missing pelvic array screw.See attachment 1 for image of the instrument.Dimensional inspection: dimensional inspection was not completed since visual inspection and functional inspection confirmed missing pelvic array screw.Functional inspection: functional inspection and visual inspection confirmed pelvic array screw was missing.Product history review: review of the device history records indicate 55 devices were manufactured and accepted into final stock on 09/03/2011.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 19110711 shows 2 additional complaints related to the failure in this investigation.The complaint are (b)(4).Conclusions: visual and functional inspection confirmed pelvic array screw was missing.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there have been no nc and capa associated with the product and failure mode reported in this event.Device not returned.
Event or Problem Description
Tha event description: the screw that tightens the pelvic array to the pelvic array clamp broke.Surgical delay 4 minutes.

• 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: 8221617
• Report Number: 3005985723-2019-00024
• Device Sequence Number: 197142
• Product Code: OLO
• UDI-Device Identifier: 00848486002923
• UDI-Public: 00848486002923
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 05/09/2019

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: 19110711
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/02/2019
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 01/07/2019
• Supplement Report FDA Received Date: 05/09/2019
• 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