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

Catalog Number 212480

Device Problems Mechanical Problem (1384); Insufficient Information (3190)

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

Event Date 12/12/2017

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

Upon switching sawblade attachments during total knee procedure, the angled sawblade attachment would not tighten to hold the sawblade in place.There was a 30 minute delay while we waited for previously used attachment to be cleaned and sterilized.

Manufacturer Narrative

Reported event: upon switching sawblade attachments during total knee procedure, the angled sawblade attachment would not tighten to hold the sawblade in place.There was a 30 minute delay while we waited for previously used attachment to be cleaned and sterilized device evaluation and results: not performed as the product was not returned for evaluation.The described failure mode could be caused by fracture of the locking mechanism components device history review a review of the device history records shows that on 12/6/16 28 parts were inspected, and accepted with no failures reported.Complaint history review a review of complaints in catsweb and trackwise related to p/n 212480, lot number 3500394 shows no additional complaints related to the failure in this investigation.Conclusions: the failure mode could not be confirmed because the part was not available for evaluation.If additional information that would change this investigation becomes available, this investigation will be reopened.The issue occurred during a case and resulted in a 30 minute delay.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.The device was not returned for evaluation.

Event Description

Upon switching sawblade attachments during total knee procedure, the angled sawblade attachment would not tighten to hold the sawblade in place.There was a 30 minute delay while we waited for previously used attachment to be cleaned and sterilized.

Manufacturer Narrative

Follow-up #2 and final report submitted to update sections g4, g.5.

Event Description

Upon switching sawblade attachments during total knee procedure, the angled sawblade attachment would not tighten to hold the sawblade in place.There was a 30 minute delay while we waited for previously used attachment to be cleaned and sterilized.

• Brand Name: 2.7 DEGREE ANGLED SAGITAL SAW
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 7147324
• MDR Text Key: 96054940
• Report Number: 3005985723-2017-00650
• Device Sequence Number: 1
• Product Code: OLO
• 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,Followup
• Report Date: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 212480
• Device Lot Number: 3500394 / 35021116
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization