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

Model Number 212480

Device Problem Residue After Decontamination (2325)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2021

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

Lubricant was found leaking from saw attachments.The spd manager insists all saw attachments be exchanged.Patient was not under anesthesia.Case type / application: tka.

Manufacturer Narrative

Reported issue - lubricant was found leaking from saw attachments.The spd manager insists all saw attachments be exchanged.Patient was not under anesthesia.Case type / application: tka product inspection ¿ functional inspection did not confirm the event.Grease was not present.Product history review - review of the device history records indicate devices, including serial number (b)(6), were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review ¿ a review of complaints in catsweb and trackwise related to p/n 212480, lot number 35010817 shows 00 additional complaint related to the failure in this investigation.Nc/capa history review - a review of stryker¿s nc/capa database indicated there have been no nc and capa associated with the product and failure mode reported in this event.Conclusion ¿ preventive maintenance is where an action occurs that identifies device deterioration which may compromise function.Under pm conditions no patient was involved and no actual or potential patient harm existed for the alleged event.The failure was not confirmed via inspection.No additional investigation or specific actions are required.If additional information is received, then the complaint will be reopened.

Event Description

Lubricant was found leaking from saw attachments.The spd manager insists all saw attachments be exchanged.Patient was not under anesthesia.Case type / application: tka.

• 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
• MDR Report Key: 11720459
• MDR Text Key: 250324176
• Report Number: 3005985723-2021-00075
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486032128
• UDI-Public: 00848486032128
• 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: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• 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: 35010817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Date Manufacturer Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other