MAUDE Adverse Event Report: MAKO SURGICAL CORP. 2.7 DEGREE ANGLED SAGITAL SAW; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	212480
Medical Device Problem Code	Application Program Problem: Parameter Calculation Error (1449)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Mako angled saw attachment locking mechanism is broken.It will not hold the saw in place and as a result has about 2mm of toggle in the blade.This introduces 2mm of inaccuracy during cuts and was evident during the case.Initially the surgeon aligned the saw for the distal femoral cut and started the saw blade off the bone.Before cutting the bone, the surgeon made a comment that the saw seemed to have more vibration than usual so we re checked the saw checkpoint with the green probe and it passed.The surgeon performed both angled saw cuts and proceeded to the straight attachment cuts.We then trailed the femur and it wasn't sitting flush.I got the surgeon to check his cuts with the planar probe and both the distal and posterior chamfer were off by about 2mm.We then switched the saw attachment and recut both that were off.The surgeon noticed the difference in amount of bone that was cut and was satisfied when he re checked the cuts and trailed the femur again.Upon examining the old attachment with the saw attached, there was visible ¿play/toggle¿ when the saw was ¿locked in¿.Mako tka 2.0.
Additional 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 if additional information becomes available.

• Brand Name: 2.7 DEGREE ANGLED SAGITAL SAW
• Common Device Name: 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: alessandra chavez ; 3365 enterprise ave; weston, FL 33331 ; 9546280700
• MDR Report Key: 20540078
• Report Number: 3005985723-2024-00219
• Device Sequence Number: 15113600
• Product Code: OLO
• UDI-Device Identifier: 00848486032128
• UDI-Public: 00848486032128
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K172219
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/25/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 212480
• Device Lot Number: LOT 35060624 SN 354428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Female