MAUDE Adverse Event Report: MAKO SURGICAL CORP. 2.7 DEGREE ANGLED SAGITAL SAW; STEREOTAXIC DEVICE, ROBOTICS

Model Number	212480
Medical Device Problem Codes	Positioning Failure (1158); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During a right mako tka, after the first 2 cuts with the angled saw attachment (distal and posterior chamfer), both cuts were checked and were both 2-2.5mm deep.We confirmed this with the x-ray as well as the green probe and both showed the same deep result.When cutting there was no yellow warning to suggest the cut was deep.Also, the angled saw attachment had been checked with the sawblade checkpoint prior to and after the cuts and was 0.4.The femoral array was also checked and was 0.3.When trialling the femoral implant had a 2mm gap distally so we had to use cemented implants which is not the surgeon¿s preference.All of the cuts made with the straight saw attachment were within 0.5 of the planned cut.Not as precise tka which is why the surgeon uses mako.We had to use a cemented implant to fill the 2mm gap due to the deep distal and posterior chamfer cut.
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 when additional information becomes available.
Event or Problem Description
During a right mako tka, after the first 2 cuts with the angled saw attachment (distal and posterior chamfer), both cuts were checked and were both 2-2.5mm deep.We confirmed this with the x-array as well as the green probe and both showed the same deep result.When cutting there was no yellow warning to suggest the cut was deep.Also, the angled saw attachment had been checked with the sawblade checkpoint prior to and after the cuts and was 0.4.The femoral array was also checked and was 0.3.When trialling the femoral implant had a ~2mm gap distally so we had to use cemented implants which is not the surgeon¿s preference.All of the cuts made with the straight saw attachment were within 0.5 of the planned cut.Not as precise tka which is why the surgeon uses mako.We had to use a cemented implant to fill the 2mm gap due to the deep distal and posterior chamfer cut.
Additional Manufacturer Narrative
Update on july 12,2023 - on initial receipt of the reported event, the event description was reviewed with the information available at that time, a decision was made to report the event.The case type was reported as tka 2.0, therefore this event does not meet the reportable criteria and will be rationale per the total knee arthroplasty mako system a0032964 rev.Ae.Under hazardous situation "bone preparation: system outputs incorrect resection visuals leading to user failing to resect to plan.It can now be concluded that the reported event does not meet the criteria of a reportable event as per our risk documentation.Therefore this mdr is being cancelled.

• Brand Name: 2.7 DEGREE ANGLED SAGITAL SAW
• 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: 16712808
• Report Number: 3005985723-2023-00067
• Device Sequence Number: 15269798
• Product Code: OLO
• UDI-Device Identifier: 00848486032128
• UDI-Public: 00848486032128
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K143752
• 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): 07/13/2023

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: 212480
• Device Catalogue Number: 212480
• Device Lot Number: SN 3523516 LOT 35060522
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2023
• Supplement Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/03/2022
• 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 Age: 63 YR
• Patient Sex: Female