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	12/03/2018
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
While impacting the cup a vizadisc flew off of the pelvic array.We replaced the vizadisc and made sure it securely snapped on to the peg on the array.Impacted again, same thing happened, same vizadisc flew off.This happened multiple times.Surgical delay- 15 minutes.Case type: tha.
Additional Manufacturer Narrative
Follow-up #1 and final report submitted based on the results of investigation.Reported event: it was reported that while impacting the cup a vizadisc flew off of the pelvic array.We replaced the vizadisc and made sure it securely snapped on to the peg on the array.Impacted again, same thing happened, same vizadisc flew off.This happened multiple times.Product evaluation and results: the product was not evaluated as the product was unavailable for inspection capa 2127499 has been raised for the same.Product history review: review of the device history records indicate (b)(4) devices were manufactured under lot 19470117 and accepted into final stock on 04/07/2017.No non-conformance were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 112230, lot number 19470117 shows no additional complaints related to the failure in this investigation.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.H3 other text : product was not available for evaluation.
Event or Problem Description
While impacting the cup a vizadisc flew off of the pelvic array.We replaced the vizadisc and made sure it securely snapped on to the peg on the array.Impacted again, same thing happened, same vizadisc flew off.This happened multiple times.Surgical delay- =15 minutes.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: 8200163
• Report Number: 3005985723-2018-00785
• Device Sequence Number: 11276690
• Product Code: OLO
• UDI-Device Identifier: 00848486002923
• UDI-Public: 00848486002923
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 08/30/2019

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: 19470117
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/03/2018
• Supplement Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 08/30/2019
• 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