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

Model Number 212480

Device Problems Device Slipped (1584); Appropriate Term/Code Not Available (3191)

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

Event Date 07/21/2021

Event Type  malfunction  

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 bone prep the doctor said that the screen was showing him cutting more medially than he actually was for the distal, posterior chamfer and posterior cuts.We ruled out any bumped bone arrays, checkpoints and base array/registration errors.No surgical delay.Case type / application: tka.

Event Description

During bone prep the doctor said that the screen was showing him cutting more medially than he actually was for the distal, posterior chamfer and posterior cuts.We ruled out any bumped bone arrays, checkpoints and base array/registration errors.No surgical delay.Case type / application: tka.

Manufacturer Narrative

Reported event: an event regarding locking mechanism failure involving a mako saw attachment was reported.The event was confirmed.Method & results: product evaluation and results: functional verification confirmed the event, the racheting mechanism was broken and would not hold the saw properly to make the cuts.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate devices, including serial number (b)(6), were manufactured and accepted into final stock on with no relevant reported discrepancies.Complaint history review: there have been 2 other similar events for the lot referenced.Conclusions: the alleged failure mode was confirmed.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.

• Brand Name: 2.7 DEGREE ANGLED SAGITAL SAW
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12320972
• MDR Text Key: 266680131
• Report Number: 3005985723-2021-00139
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486032128
• UDI-Public: 00848486032128
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• 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: 35070619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2019
• 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