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

Catalog Number 212186

Device Problems Mechanical Problem (1384); Premature Separation (4045)

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

Event Date 08/14/2019

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

Angled saw attachment would not tighten down and the blade kept falling out during cuts.Case type: tka.Surgical delay: <= 15 minutes.

Manufacturer Narrative

It was reported that the angled saw attachment would not tighten down and the blade kept falling out during cuts.Product evaluation and results: functional inspection: the functional inspection revealed that the locking knob / mechanism was broken and not operating as intended.Visual inspection: no issues detected other than normal wear and tear.Dimensional inspection: not performed as the item has been used and the dimensions and tolerances on the print are no longer accurately represented by the part.Material analysis: not performed as no material failure is alleged.Product history review: review of the product history records indicate a total of 50 devices were manufactured under lot 35010519 as part of two inspection batches.(b)(4) devices were manufactured and (b)(4) devices were accepted into final stock on 06/03/2019 with no reported discrepancies.(b)(4) devices were manufactured and 38 devices were accepted into final stock on 06/07/2019.Review of qt19 - 06 - 0042 revealed that the non-conformance is not related to the failure alleged in this compliant.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 212480, l/n 35010519, shows no additional complaints related to the failure in this investigation.Conclusions: a broken locking mechanism was observed upon inspection and confirms the alleged complaint.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.

Event Description

Angled saw attachment would not tighten down and the blade kept falling out during cuts.Case type: tka.Surgical delay: = 15 minutes.

• 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: 8946465
• MDR Text Key: 156023356
• Report Number: 3005985723-2019-00603
• 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: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 212186
• Device Lot Number: 35010519 / 3506782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Date Manufacturer Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization