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

Model Number	112230
Medical Device Problem Codes	Mechanical Problem (1384); Premature Separation (4045)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/07/2019
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
When impacting the vizadisc popped off the array (superior, right peg when looking at it from the back).The disc was fully seated.When inspecting the array after the case, the disc doesn¿t stay on the leg tight (it easy pulls off compared to others).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.When impacting the vizadisc popped off the array (superior, right peg when looking at it from the back).The disc was fully seated.When inspecting the array after the case, the disc doesn¿t stay on the leg tight (it easy pulls off compared to others).Product evaluation and results: functional inspection: tested with known good vizadisc on the array and functioned as intended.Vizadisc were mounted on pegs and impaction was done to replicate the issue but the vizadisc did not fall off hence the failure was not confirmed.Product history review: review of the product history records indicate (b)(4) devices were manufactured under lot no 19030315 and accepted into final stock on 07/16/ 2016.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 19030315 shows no additional complaints related to the failure in this investigation.Conclusions: the failure was not confirmed via functional inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.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.
Event or Problem Description
When impacting the vizadisc popped off the array (superior, right peg when looking at it from the back).The disc was fully seated.When inspecting the array after the case, the disc doesn¿t stay on the leg tight (it easy pulls off compared to others).Case type: tha.

• 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: 9396899
• Report Number: 3005985723-2019-00887
• Device Sequence Number: 19508368
• Product Code: OLO
• UDI-Device Identifier: 00848486002923
• UDI-Public: 00848486002923
• 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): 02/03/2020

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 Model Number: 112230
• Device Catalogue Number: 112230
• Device Lot Number: 19030315
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/07/2019
• Supplement Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 02/04/2020
• 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
• Patient Age: 69 YR