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

Model Number 209063

Device Problems Failure to Cut (2587); Complete Loss of Power (4015)

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

Event Date 03/18/2021

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.Mics headpiece- serial number specific recall was initiated for the mics handpieces within scope of a capa.The investigation revealed that only specific the catalog number and serial numbers are impacted by the regulatory action.The root cause analysis identified a characterization issue associated with the mako integrated cutting system (mics) handpiece.Users have been instructed to return any specified hand piece to stryker.

Event Description

Mics power would not pass multiple angled saw attachments prior to bone resection.No surgical delay.Case type / application: tka.

Event Description

Mics power would not pass multiple angled saw attachments prior to bone resection.No surgical delay.Case type / application: tka.

Manufacturer Narrative

Reported event an event regarding non functional involving a mako mics was reported.The event was not confirmed during inspection.Method & results product evaluation and results: handpiece mics ¿ 209063 ¿ serial#(b)(6) - rma#(b)(4).Inspected per d06917 and was unable to determine the failure of any test steps.Original description not confirmed.Disposition: rtv inspected clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate devices, including serial number (b)(6), were manufactured and accepted into final stock 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 not confirmed during inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.

• 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: 11655846
• MDR Text Key: 246010229
• Report Number: 3005985723-2021-00068
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030193
• UDI-Public: 00848486030193
• Combination Product (y/n): N
• 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: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 209063
• Device Catalogue Number: 209063
• Device Lot Number: 42030720 / 4209813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2021
• Date Manufacturer Received: 08/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0472-2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other