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

Model Number 212186

Device Problem Fluid/Blood Leak (1250)

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

Event Date 08/31/2020

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

Straight saw attachment had oil leaking from it when opening trays pre-op.Blue square driver: handle moving independently from the driver.No surgical delay.Case type / application: tka.

Event Description

1) straight saw attachment had oil leaking from it when opening trays pre-op.2) blue square driver: handle moving independently from the driver.No surgical delay.Case type / application: tka.

Manufacturer Narrative

Reported issue - 1) straight saw attachment had oil leaking from it when opening trays pre-op.2) blue square driver: handle moving independently from the driver.No surgical delay.Case type / application: tka product inspection ¿ visual inspection confirmed the event.There is oil residue on the attachment.See attached image.Product history review ¿ review of the device history records indicate 50 devices were manufactured and 50 were accepted (including serial (b)(6) into final stock on 01/16/2018 with no reported discrepancies.Complaint history review ¿ a review of complaints in catsweb and trackwise related to p/n 212186, lot number 35011217 shows 00 additional complaints related to the failure in this investigation.Conclusion ¿ the event was confirmed via visual 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.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 10574524
• MDR Text Key: 208184321
• Report Number: 3005985723-2020-00303
• 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: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• 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: 35011217 / 3502814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Date Manufacturer Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR