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

Model Number 212480

Device Problems Positioning Failure (1158); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 03/14/2023

Event Type  malfunction  

Event 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.

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 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.

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
• 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: 16712808
• MDR Text Key: 313026182
• Report Number: 3005985723-2023-00067
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486032128
• UDI-Public: 00848486032128
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K143752
• 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: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 03/14/2023
• Initial Date FDA Received: 04/11/2023
• Supplement Dates Manufacturer Received: 06/22/2023
• Supplement Dates FDA Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/03/2022
• 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
• Patient Age: 63 YR
• Patient Sex: Female