MAUDE Adverse Event Report: MAKO SURGICAL CORP. HANDPIECE MICS; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 209063

Device Problems Application Program Problem: Parameter Calculation Error (1449); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2022

Event Type  malfunction  

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.Device not returned.

Event Description

During registration we had a difficult time verifying rio registration.After numerous attempts verification passed.After we made our cuts in the planar workflow we attempted to move on to our burring.The burr would not pass.We checked all physicals and registration tool was flush with end effector.All discs were flush.We attempted to re register the mics with dr.And the registration would not pass.We changed out mics power, re registered and entered back into the case.Case type / application: pka (mics).

Manufacturer Narrative

Upon further review it has been determined that this event is not reportable.The awareness date of this event is after this device was received and repaired by the manufacturer, which makes this event out of scope of recall z-0472-2021; therefore, this mdr is being cancelled.The event is covered under the partial knee arthroplasty mako system risk table, hazardous situation ¿user is not provided adequate indication for registration confirmation¿ that the highest potential severity of harm is s1.

Event Description

During registration we had a difficult time verifying rio registration.After numerous attempts verification passed.After we made our cuts in the planar workflow we attempted to move on to our burring.The burr would not pass.We checked all physicals and registration tool was flush with end effector.All discs were flush.We attempted to re register the mics with dr.And the registration would not pass.We changed out mics power, re registered and entered back into the case.Case type / application: pka (mics).

• Brand Name: HANDPIECE MICS
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• Manufacturer (Section G): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• Manufacturer Contact: kelsey williams ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15938049
• MDR Text Key: 308189709
• Report Number: 3005985723-2022-00162
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030193
• UDI-Public: 00848486030193
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 209063
• Device Catalogue Number: 209063
• Device Lot Number: 42090720 / 4209955
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Sex: Male