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

Model Number	112280
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Tibia registration could not be completed.They found the base of the array was moved.
Additional 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 or Problem Description
Tibia registration could not be completed.They found the base of the array was moved.

• Brand Name: TIBIAL ARRAY
• Common Device Name: 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
• Report Number: 3005985723-2023-00022
• Device Sequence Number: 15614802
• Product Code: OLO
• UDI-Device Identifier: 00848486015923
• UDI-Public: 00848486015923
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2023
• Supplement Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown