MAUDE Adverse Event Report: MAKO SURGICAL CORP. BASE BAR ASSM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 210060

Device Problems Degraded (1153); Material Frayed (1262)

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

Event Date 02/24/2020

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

F-bar is beginning to splinter.Case type: tka.

Event Description

F-bar is beginning to splinter.Case type: tka.

Manufacturer Narrative

Update to b2 and d2.Reported issue - f-bar is beginning to splinter.Product inspection - visual inspection of catalog #210060, lot/serial (b)(6) confirms the base bar has splintered along the side of the bar.See image attached.Product history review ¿ review of the device history records for catalog #210060, lot/serial (b)(6) indicates (b)(4) devices were manufactured and all (b)(4) devices were accepted into final stock on 12/27/2018 with no reported discrepancies.Complaint history review ¿ a review of complaints in catsweb and trackwise related to p/n 210060, lot #615603 shows 0 additional complaints related to the failure in this investigation.Conclusion ¿ the event was confirmed.There was splintering noticed along the base bar.

• Brand Name: BASE BAR ASSM
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9850208
• MDR Text Key: 184174883
• Report Number: 3005985723-2020-00166
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486031855
• UDI-Public: 00848486031855
• 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: 06/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 210060
• Device Catalogue Number: 210060
• Device Lot Number: 615603
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other