MAUDE Adverse Event Report: MAKO SURGICAL CORP. RIO®SHELL IMPACT-OFFSET-TRIDENT PST; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	209830
Medical Device Problem Codes	Fracture (1260); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/26/2019
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
As reported: "the impactor shaft end sheared off inside of the impactor platform.During impaction.The case was completed successfully".Case type: tha.As per the mps: "the impactor shaft was the only item that broke, it broke inside the intact platform".
Event or Problem Description
As reported: "the impactor shaft end sheared off inside of the impactor platform.During impaction.The case was completed successfully." case type: tha as per the mps: "the impactor shaft was the only item that broke, it broke inside the intact platform.".
Additional Manufacturer Narrative
Reported event: it was reported that the impaction shaft was broken during impaction of the cup.Product evaluation and results: the product was unavailable for inspection as the product was not returned.Product history review: review of the device history records indicate (b)(4) devices were manufactured under lot no 32882 and accepted into final stock on 12/22/2015 and (b)(4) devices were manufactured and accepted into final stock on 12/23/2015.The rejected device was dispositioned as "return to vendor" per (b)(4) on 04/01/2016.The non conformance was unrelated to the failure in this investigation.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 209830, lot number 32882 shows 04 additional complaints related to the failure in this investigation.The complaint (b)(4).Conclusions: the failure could not be determined as the product was not available for inspection.If additional information is received the complaint 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: RIO®SHELL IMPACT-OFFSET-TRIDENT PST
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8508319
• Report Number: 3005985723-2019-00288
• Device Sequence Number: 13688421
• Product Code: OLO
• UDI-Device Identifier: 00848486030285
• UDI-Public: 00848486030285
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K141989
• 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): 06/11/2019

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: 209830
• Device Lot Number: 32882
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/26/2019
• Supplement Date Received by Manufacturer: 05/30/2019
• Initial Report FDA Received Date: 04/12/2019
• Supplement Report FDA Received Date: 06/11/2019
• 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