MAUDE Adverse Event Report: MAKO SURGICAL CORP. BOOT ASSEMBLY; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 210080

Device Problems Material Frayed (1262); Non Reproducible Results (4029)

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

Event Date 06/28/2019

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

After completing a robotic tka case, it was noticed that the fiber glass had been frayed at the tip of the boot.Case type: tka.

Manufacturer Narrative

Reported event: it was reported that "after completing a robotic tka case, it was noticed that the fiber glass had been frayed at the tip of the boot." the event was not confirmed.Method & results: device evaluation and results: not performed as no items were returned.Product history review: review of the device history records indicates (b)(4) device(s) under lot 201643122201 were manufactured and accepted into final stock on 27apr2017 with no reported discrepancies.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 210080, lot 201643122201 shows 00 additional complaint(s) related to the failure in this investigation.Conclusion: the exact cause of the event could not be determined because the product was not received.Corrective action/preventive action: no action is required at this time as there is no confirmed failure mode.

Event Description

After completing a robotic tka case, it was noticed that the fiber glass had been frayed at the tip of the boot.Case type: tka.

• Brand Name: BOOT ASSEMBLY
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8795640
• MDR Text Key: 151204966
• Report Number: 3005985723-2019-00514
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486031879
• UDI-Public: 00848486031879
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 210080
• Device Lot Number: 201643122201
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization