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

Catalog Number	209830
Medical Device Problem Codes	Contamination (1120); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/25/2019
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
Cleaning/spd issue with offset impaction handle.Black residue came out when surgeon was trying to screw cup on.Because it contaminated the entire field, the surgeon demanded both handles be removed immediately and are set aside and packaged to be sent back.We will need two offset impaction handles to replace the two we will be sending back.Case type: tha.Surgical delay: 15 minutes.
Additional Manufacturer Narrative
Follow-up #1 and final report submitted.Product identification: the returned product was confirmed to be a trident straight cup impactor, p/n 209830, l/n 32884 and rma 267260.Inspection: material analysis concluded that no biological matter was observed.Please see attached material analysis report (mar) under the communication log.Product history: review of device history records indicate that 8 devices were accepted into final stock on 07/07/16 with no reported discrepancies.Complaint history review: review of complaint within trackwise database for p/n 209830, lot 32884 shows 0 other complaints related to the failure in this investigation.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.Conclusion: functional inspection did not confirm alleged failure of improper cleaning.
Event or Problem Description
Cleaning/spd issue with offset impaction handle.Black residue came out when surgeon was trying to screw cup on.Because it contaminated the entire field, the surgeon demanded both handles be removed immediately and are set aside and packaged to be sent back.We will need two offset impaction handles to replace the two we will be sending back.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: 8351653
• Report Number: 3005985723-2019-00148
• Device Sequence Number: 2229680
• Product Code: OLO
• UDI-Device Identifier: 00848486030285
• UDI-Public: 00848486030285
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 04/08/2019

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: 32884
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/25/2019
• Supplement Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 02/19/2019
• Supplement Report FDA Received Date: 04/08/2019
• 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