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

Model Number 212186

Device Problem Contamination of Device Ingredient or Reagent (2901)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/02/2020

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

Black oil residue was found on the outside of the attachment piece after cuts were made & cut guide was difficult to dislodge from mics handpiece.Case type: tka.Update: patient was under anesthesia.

Event Description

Black oil residue was found on the outside of the attachment piece after cuts were made & cut guide was difficult to dislodge from mics handpiece.Case type: tka.Update: patient was under anesthesia.

Manufacturer Narrative

Reported event: it was reported that "black oil residue found on outside of attachment piece after cuts were made & cut guide was difficult to dislodge from mics handpiece.Case type: tka.Update: patient was under anesthesia".Product evaluation and results: visual inspection confirmed that there was black residue on the shaft gears.Product history review: 1.Review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock on 12/05/2016 with no reported discrepancies.2.Review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock on 12/01/2016 with no reported discrepancies, including serial (b)(6).3.Review of the device history records indicate (b)(4) devices were manufactured and (b)(4) accepted into final stock on 01/06/2017 with no reported discrepancies.Review revealed that the 2 devices are use as is dated 11/30/2016.The non conformance is unrelated to the failure alleged.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 212186, lot number 35011116 shows 5 additional complaints related to the failure in this investigation.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 STRAIGHT SAGITAL SAW
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9831969
• MDR Text Key: 183522390
• Report Number: 3005985723-2020-00152
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486032111
• UDI-Public: 00848486032111
• Combination Product (y/n): N
• PMA/PMN Number: K143752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• 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: 35011116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Date Manufacturer Received: 05/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization