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

Model Number 209063

Device Problems Output Problem (3005); Physical Resistance/Sticking (4012)

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

Event Date 12/07/2021

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

Trigger kept engaging without surgeon pressing it. Surgical delay:
=
15 minutes. Case type / application: pka (mics). Update: was the cutting tool on when outside of haptics? the surgeon pressed the trigger once, let it go, and the arm continued to align. Once it aligned haptics turned green and the burr started, but it was no where near the appropriate alignment would be for this procedure. Changed out the mics hand piece and then everything worked fine. Was a tourniquet used during the surgical delay? yes.

• Brand Name: HANDPIECE MICS
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood, FL WD6 3-SJ ; UK WD6 3SJ ; 9546280700
• MDR Report Key: 13150553
• MDR Text Key: 284966129
• Report Number: 3005985723-2022-00001
• Device Sequence Number: 1
• Product Code: OLO
• 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

• Type of Report: Initial,Followup
• Report Date: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 209063
• Device Catalogue Number: 209063
• Device Lot Number: 42010318 / 4203714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 01/04/2022 Patient Sequence Number: 1