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

Catalog Number	112240
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	07/15/2019
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
Array adapter broke off while tightening.Case type: tha.
Event or Problem Description
Array adapter broke off while tightening case.Type: tha.
Additional Manufacturer Narrative
Follow-up #1 and final report submitted to update sections d.3, g.1, g.4, g.7, h.2, h.3, h.6, h.10 and h.11 based on the results of investigation.Reported event: it was reported that "array adapter broke off while tightening." the event was not confirmed.Method & results: -device evaluation and results: a review of complaints in catsweb and trackwise related to p/n 112240, lot 19080913 shows 00 additional complaint(s) related to the failure in this investigation.-product history review: review of the device history records indicates 49 device(s) were manufactured and accepted into final stock on 12dec2013 and 01 device(s) were rejected.Review of qt13-12-0018 indicates the following: 01 device(s) were quarantined due to screw misplacement; the part was rtv.Product history review shows the nonconformance(s) did not contribute to the event alleged in this complaint.-complaint history review: a review of complaints in catsweb and trackwise related to p/n 112240, lot 19080913 shows 00 additional complaint(s) related to the failure in this investigation.Conclusion: the exact cause of the event could not be determined because the product was not received.Corrective action/preventive action: no action is required at this time as there is no confirmed failure mode.H3 other text : product was not available for evaluation.

• Brand Name: PELVIC ARRAY ADAPTOR ASSY
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8816992
• Report Number: 3005985723-2019-00530
• Device Sequence Number: 3109302
• Product Code: OLO
• UDI-Device Identifier: 00848486002930
• UDI-Public: 00848486002930
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/25/2019

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: 112240
• Device Lot Number: 19080913
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/15/2019
• Supplement Date Received by Manufacturer: 09/21/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 09/25/2019
• 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