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	09/06/2018
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
Adapter tightening bolt broke off in 3 pin clamp.Case type: tha.
Event or Problem Description
Adapter tightening bolt broke off in 3 pin clamp.Case type: tha.
Additional Manufacturer Narrative
Reported event: it was reported that adapter tightening bolt broke off in 3 pin clamp.Product evaluation and results: the product was unavailable for inspection as the product was not returned.Product history review: review of the product history records indicate 46 devices were manufactured under lot no 19130711 and accepted into final stock on (b)(6) 2011.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 112240, lot number 19130711, shows 01 additional complaints related to the failure in this investigation.Complaint (b)(4).Conclusions: the failure mode could not be confirmed because the part was not available for evaluation.If device and/or additional information become available, this investigation will be reopened.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 ADAPTOR ASSY
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 7925641
• Report Number: 3005985723-2018-00567
• Device Sequence Number: 11161499
• 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): 12/05/2018

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: 112240
• Device Lot Number: 19130711
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/06/2018
• Supplement Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 10/02/2018
• Supplement Report FDA Received Date: 12/05/2018
• 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