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

Model Number 212480

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/03/2020

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

Liquid leaking from angled attachment.No surgical delay.Case type / application: tka.

Manufacturer Narrative

Reported issue ¿ liquid leaking from angled attachment.No surgical delay.Case type / application: tka.Product inspection ¿ visual inspection shows oil residue from attachment.See attached image.Product history review ¿ review of the device history records indicate 45 device(s) were manufactured under catalog # 212480, ln: 35060119 and (b)(4) devices were accepted (including serial (b)(6) ) into final stock on 04 feb 2019.(b)(4) was created for the non-conformance on 04 feb 2019.A review of (b)(4) revealed the device is not related to the non-conformance.Complaint history review ¿ a review of complaints in catsweb and trackwise related catalog # 212480, ln: 35060119 shows 01 additional complaints related to the failure in this investigation.Nc/capa history review - a review of stryker¿s nc/capa database indicated there have been no ncs or capas associated with the product and failure mode reported in this event.Conclusion - failure is confirmed via inspection.No additional investigation or specific actions are required.If additional information is received, then the complaint will be reopened.

Event Description

Liquid leaking from angled attachment.No surgical delay.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: 10918564
• MDR Text Key: 220246719
• Report Number: 3005985723-2020-00371
• 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: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2020
• 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: 35060119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Date Manufacturer Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other