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

Model Number 212186

Device Problems Fracture (1260); Contamination of Device Ingredient or Reagent (2901)

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

Event Date 10/29/2019

Event Type  malfunction  

Manufacturer Narrative

As part of the 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

Seal broke on saw attachment.Fluid leaked out.Case type: tka.Surgical delay: = 15 minutes.

Manufacturer Narrative

Update to b2 and d2.Reported event: it was reported that seal broke on saw attachment.Fluid leaked out.Product evaluation and results: functional inspection confirmed the internal shaft gears were catching which confirmed the seal was broken on the attachment as this did not allow the attachment to lock fully on the blade.No fluid was found, however.Grease marks were found on the attachment.Product history review: review of the device history records indicate (b)(4) were manufactured as part of lot 35020517 and (b)(4) were accepted into final stock on 06/29/17 (inducing s/n (b)(6)).Review of qt 17-06-0092 showed the non-conformance was not related to the failure alleged in this complaint.The 09 rejected devices were re-inspected and (b)(4) were accepted into final stock on 01/02/2018; (b)(4) was accepted into final stock on 05/15/2018; (b)(4) accepted into final stock on 05/24/2018.The non conformance is not related to the failure alleged in this complaint.Complaint history review: 1.A review of complaints in catsweb and trackwise related to p/n 212480, lot 35020517 shows 7 additional complaints related to the failure of locking mechanism in this investigation.2.A review of complaints in catsweb and trackwise related to p/n 212480, lot 35020517 shows 3 additional complaints related to the failure of foreign matter in this investigation.Conclusions: the 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

Seal broke on saw attachment.Fluid leaked out.Case type: tka.Surgical delay: = 15 minutes.

• 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: 9375912
• MDR Text Key: 168014249
• Report Number: 3005985723-2019-00842
• 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: 05/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• 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: 3501543
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other