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

Model Number 209063

Device Problem Intermittent Loss of Power (4016)

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

Event Date 10/25/2020

Event Type  malfunction  

Manufacturer Narrative

Serial specific voluntary recall was initiated for the mako integrated cutting system (mics) within scope of a capa.The initial root cause analysis determined that the process for characterizing mics handpieces for specific serial numbers deviated from its qualified state at the time of validation.The capa investigation is currently in progress and an updated communication will be submitted upon completion of the investigation.

Event Description

Blade would not pass during bone prep after all problem solving.Case type / application: tka.Surgical delay= 15 minutes.

Manufacturer Narrative

Reported event: an event regarding registration fails involving a mako mics was reported.The event was not confirmed.Method & results: product evaluation and results: the failure is confirmed as it is under the scope of nc mics characterization process deviated from the qualified state.Also the serial number (b)(6) lies in the urgent medical device recall list.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate 24 devices, including serial number (b)(6), were manufactured and accepted into final stock on 12 june, 2016 with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the alleged failure mode was confirmed.No additional investigation or specific actions are required.H3 other text : device not returned.

Event Description

Blade would not pass during bone prep after all problem solving.Case type / application: tka; surgical delay<= 15 minutes.

• Brand Name: HANDPIECE MICS
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 10853037
• MDR Text Key: 218252001
• Report Number: 3005985723-2020-00362
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030193
• UDI-Public: 00848486030193
• Combination Product (y/n): N
• PMA/PMN Number: K142530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• 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: 42021016 / 4201236
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0472-2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other