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); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/29/2019
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
Visadisc detached from bottom right peg of pelvic array during impaction.This happened on multiple occasions with impaction.Eventually, tried a different visadisc and issue continued to occur.After inspection, visadiscs seemed to come off of that particular peg easier than others.Casse type: tha.
Event or Problem Description
Visadisc detached from bottom right peg of pelvic array during impaction.This happened on multiple occasions with impaction.Eventually, tried a different visadisc and issue continued to occur.After inspection, visadiscs seemed to come off of that particular peg easier than others.Casse 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 "visadisc detached from bottom right peg of pelvic array during impaction.This happened on multiple occasions with impaction.Eventually, tried a different visadisc and issue continued to occur.After inspection, visadiscs seemed to come off of that particular peg easier than others." the event was not confirmed.Method & results: -device evaluation and results: not performed as no items were returned.-product history review: a review of the device history records indicate 50 devices were manufactured under lot 19031117 and were accepted into final stock on 01/12/2018.No non- conformance were identified during inspection.-complaint history review: a review of complaints in catsweb and trackwise related to p/n 112230, lot 19031117 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 : device not returned.

• 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: 8358265
• Report Number: 3005985723-2019-00176
• Device Sequence Number: 16701627
• Product Code: OLO
• UDI-Device Identifier: 00848486002923
• UDI-Public: 00848486002923
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 07/17/2019

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: 19031117
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/29/2019
• Supplement Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 02/21/2019
• Supplement Report FDA Received Date: 07/17/2019
• 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