MAUDE Adverse Event Report: MAKO SURGICAL CORP. SHELL IMPACTION PLATFORM; STEREOTAXIC DEVICE, ROBOTICS

Model Number	206270
Medical Device Problem Code	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 fractured while surgeon was impacting cup.Impactor plate and hip end effector were damaged as well, i had 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 (b)(4) shell impaction platform.Associated complaints from the same surgery include: (b)(4).Update: "yes, the patient was under anesthesia.".
Additional Manufacturer Narrative
This report was found to be a duplicate.All further information will be captured and reported under mfr# 3005985723-2019-00705.
Event or Problem Description
Inline offset impactor fractured while surgeon was impacting cup.Impactor plate and hip end effector were damaged as well, i had 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 206270 shell impaction platform.Associated complaints from the same surgery include: pi 2198767, pi 2198777 and pi 2198959.Update: "yes, the patient was under anesthesia.".

• Brand Name: SHELL IMPACTION PLATFORM
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9141694
• Report Number: 3005985723-2019-00711
• Device Sequence Number: 3007798
• Product Code: OLO
• UDI-Device Identifier: 00848486022082
• UDI-Public: 00848486022082
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/09/2020

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: 206270
• Device Catalogue Number: 206270
• Device Lot Number: 45021215
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/25/2019
• Supplement Date Received by Manufacturer: 04/09/2020
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 04/09/2020
• 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