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

Model Number	209830
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/25/2019
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
Inline offset impactor was damaged while surgeon was impacting cup.Impactor plate and hip end effector were damaged as well, i had a replacement set of instruments to open onto the sterile field, surgeon had difficulty removing broken instruments off of the robot, which added to the delay in surgery.Case type: tha.Surgical delay: 35 minutes.This complaint is for the rio shell impact-offset-trident pst.Associated complaints from the same surgery include: (b)(6).
Additional Manufacturer Narrative
Reported event: it was reported that inline offset impactor was damaged while surgeon was impacting cup.Impactor plate and hip end effector were damaged as well, i had a replacement set of instruments to open onto the sterile field, surgeon had difficulty removing broken instruments off of the robot, which added to the delay in surgery.Case type: tha.Surgical delay: 35 minutes.This complaint is for the rio shell impact-offset-trident pst.Associated complaints from the same surgery include: (b)(4).Product evaluation and results: (b)(4) could not be completed as the 206270 shell impaction platform was not provided.Three communication attempts were made and appropriate information was not received.Product was not returned.Product history review: review of the product history records indicate (b)(4) devices were manufactured under lot no 33851 and accepted into final stock on 10/04/2016 with no reported discrepancies.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 209830, lot 33851 shows 0 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.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there have been no nc and capa associated with the product and failure mode reported in this event.H3 other text : device not returned.
Event or Problem Description
Inline offset impactor was damaged while surgeon was impacting cup.Impactor plate and hip end effector were damaged as well, i had a replacement set of instruments to open onto the sterile field, surgeon had difficulty removing broken instruments off of the robot, which added to the delay in surgery.Case type: tha.Surgical delay: 35 minutes.This complaint is for the rio shell impact-offset-trident pst.Associated complaints from the same surgery include: (b)(4).

• 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: 9147805
• Report Number: 3005985723-2019-00713
• Device Sequence Number: 2656313
• Product Code: OLO
• UDI-Device Identifier: 00848486030285
• UDI-Public: 00848486030285
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/01/2020

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 Model Number: 209830
• Device Catalogue Number: 209830
• Device Lot Number: 33851
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/25/2019
• Supplement Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 10/02/2019
• Supplement Report FDA Received Date: 04/01/2020
• 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