MAUDE Adverse Event Report: MAKO SURGICAL CORP. HANDPIECE MICS; STEREOTAXIC DEVICE, ROBOTICS

Model Number 209063

Device Problems Loss of Power (1475); Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/23/2019

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

When performing our initial resection cut, the mics power stopped working mid cut as if it lost power.As new mics hand piece was being changed, a rotational bolt fell out of the opening of the hand piece.Case type: tka.Intra op delay of 4 mins.

Manufacturer Narrative

When performing our initial resection cut, the mics power stopped working mid cut as if it lost power.As new mics hand piece was being changed, a rotational bolt fell out of the opening of the hand piece.Case type: tka.Intra op delay of 4 mins.Product inspection: mics-209063, sn# (b)(6), lot#42030218, rma#281028.Inspected per (b)(4) and determined failure of the following test step.Sec# 7.1.4: failed collar test.Disposition: rtv.Device history review: device history records indicate (b)(4) devices were manufactured under lot k0awu and (b)(4)devices were accepted into final stock on 03/08/2018.A review of qt18-03-0020 revealed that the issue 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 209063, lot number 42030218 shows 6 additional complaints related to the failure in this investigation.Conclusion: the alleged failure mode was confirmed.No additional investigation or specific actions are required.¿if additional information is received then the complaint will be reopened.

Event Description

When performing our initial resection cut, the mics power stopped working mid cut as if it lost power.As new mics hand piece was being changed, a rotational bolt fell out of the opening of the hand piece.Case type: tka.Intra op delay of 4 mins.

• Brand Name: HANDPIECE MICS
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9119593
• MDR Text Key: 160154495
• Report Number: 3005985723-2019-00695
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030193
• UDI-Public: 00848486030193
• Combination Product (y/n): N
• PMA/PMN Number: K142530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 209063
• Device Catalogue Number: 209063
• Device Lot Number: 42030218 / 4203617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2019
• Date Manufacturer Received: 12/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization