MAUDE Adverse Event Report: MAKO SURGICAL CORP. TIBIAL ARRAY; STEREOTAXIC DEVICE, ROBOTICS

Model Number 112280

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Read Input Signal (1581)

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

Event Date 01/24/2023

Event Type  malfunction  

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 Description

Tibia registration could not be completed.They found the base of the array was moved.

Manufacturer Narrative

Reported event: an event regarding registration fails involving a mako arrays was reported.The event was not confirmed because the product was not available for inspection.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there are no other complaints with a similar failure mode for this lot.Conclusions: the alleged failure mode was not confirmed because the product was not available for inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.H3 other text: not available.

Event Description

Tibia registration could not be completed.They found the base of the array was moved.

• Brand Name: TIBIAL ARRAY
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16319166
• MDR Text Key: 309086348
• Report Number: 3005985723-2023-00022
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486015923
• UDI-Public: 00848486015923
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 112280
• Device Catalogue Number: 112280
• Device Lot Number: 19200719
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/15/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/23/2020
• 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