MAUDE Adverse Event Report: MAKO SURGICAL CORP. RIO® SHELL IMPACTOR-STRAIGHT REST PST; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	209037
Medical Device Problem Codes	Mechanical Problem (1384); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/12/2018
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
During cup impaction the impaction shaft broke from the cup at the threads.The impaction shaft was replaced and the damaged cup was removed an replaced with no harm to the patient.Tha case was there a surgical delay? yes =15 minutes.
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 the impactor was broken during the case.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 (b)(4) devices were manufactured under lot no 22107101 and accepted into final stock on 11/14/2013.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 209037, lot number 22107101 shows no additional complaints related to the failure in this investigation.Conclusions: the failure could not be determined as the product was not available for inspection.If additional information is received then 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.
Event or Problem Description
During cup impaction the impaction shaft broke from the cup at the threads.The impaction shaft was replaced and the damaged cup was removed an replaced with no harm to the patient.Tha case was there a surgical delay? yes - =15 minutes.

• Brand Name: RIO® SHELL IMPACTOR-STRAIGHT REST PST
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 7698677
• Report Number: 3005985723-2018-00425
• Device Sequence Number: 19086659
• Product Code: OLO
• UDI-Device Identifier: 00848486022907
• UDI-Public: 00848486022907
• Combination Product (Y/N): N
• 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: 209037
• Device Lot Number: 22107101
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/12/2018
• Supplement Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 07/18/2018
• 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