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

Catalog Number 209063

Device Problem Application Program Problem: Parameter Calculation Error (1449)

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

Event Date 03/18/2024

Event Type  malfunction  

Event Description

Made distal and posterior chamfer cut, when switching to sagittal saw blade - blade did not pass- went to re register for bumped base array registration passed - verification failed several times.Failed mics status check.Case type / application: tka.

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 if additional information becomes available.

• Brand Name: HANDPIECE MICS
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• 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: 19085452
• MDR Text Key: 340680172
• Report Number: 3005985723-2024-00041
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030193
• UDI-Public: 00848486030193
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172219
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/10/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 209063
• Device Lot Number: 42020816/ 4201014
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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