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

Catalog Number	209830
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/03/2019
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
Went to impact cup, mako shell impactor and offset shell impactor broke upon contact.High volume account needing replacement asap.Case type: tha surgical delay: =15 minutes.
Additional Manufacturer Narrative
Follow-up #1 and final report submitted based on the results of investigation.It was reported that went to impact cup, mako shell impactor and offset shell impactor broke upon contact.High volume account needing replacement asap.Case type: tha.Surgical delay: =15 minutes.Product evaluation and results: (b)(4) could not be completed as the 209830 rio shell impact-offset-trident pst was not provided.Three communication attempts were made and appropriate information was not received from the rep.Product was not returned.Product history review: review of the product history records indicate (b)(4) devices were manufactured under lot no 34177 and all were accepted into final stock on 09/23/2016 with no reported discrepancies.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 209830, lot 34177 shows (b)(4) additional complaints related to the failure in this investigation.Conclusions: the failure could not be determined as the product was not available for inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.
Event or Problem Description
Went to impact cup, mako shell impactor and offset shell impactor broke upon contact.High volume account needing replacement asap.Case type: tha.Surgical delay: =15 minutes.

• 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: 8966876
• Report Number: 3005985723-2019-00647
• Device Sequence Number: 2099570
• Product Code: OLO
• UDI-Device Identifier: 00848486030285
• UDI-Public: 00848486030285
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 01/16/2020

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 Catalogue Number: 209830
• Device Lot Number: 34177
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/03/2019
• Supplement Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 09/05/2019
• Supplement Report FDA Received Date: 01/16/2020
• 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