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

Model Number 212186

Device Problem Residue After Decontamination (2325)

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

Event Date 07/12/2022

Event Type  malfunction  

Event Description

Probe will not pass probe check.Cutting attachment has brown rust residue coming out from inside the piece.No surgical delay.Case type / application: tka.

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

Probe will not pass probe check.Cutting attachment has brown rust residue coming out from inside the piece.No surgical delay.Case type / application: tka.

Manufacturer Narrative

Reported event an event regarding foreign matter involving a mako saw attachment was reported.The event was not confirmed because the product was not available for inspection.Method & results product evaluation and results: the product was not evaluated as the product was unavailable for inspection.If additional information is received, then the complaint will be reopened.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there are no other complaints with a similar failure mode for this lot.Conclusions: the alleged failure mode was not confirmed because the product was not available for inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.

• Brand Name: 2.7 DEGREE STRAIGHT SAGITAL SAW
• 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: 15144748
• MDR Text Key: 301096632
• Report Number: 3005985723-2022-00102
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486032111
• UDI-Public: 00848486032111
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 212186
• Device Catalogue Number: 212186
• Device Lot Number: 350109918 / 3504018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/04/2023
• 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
• Patient Sex: Male