MAUDE Adverse Event Report: MAKO SURGICAL CORP. HANDPIECE MICS; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 209063

Device Problems Positioning Failure (1158); Separation Failure (2547); Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2021

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

Mic is really loud with flat saw.Cuts were proud and a mallet is needed to get attachments out.Black residue building up on the outside of the mics.Surgical delay = 15 minutes.Case type / application: tka.

Event Description

Mic is really loud with flat saw.Cuts were proud and a mallet is needed to get attachments out.Black residue building up on the outside of the mics.Surgical delay = 15 minutes.Case type / application: tka.

Manufacturer Narrative

Reported event: an event regarding noise involving a mako mics was reported.The event was not confirmed because the product was not available for inspection.Method & results: product evaluation and results: product inspection could not be performed as the product was not made available for evaluation within 60 days of the complaint being opened.The complaint will be closed with an associated risk assessment.Additional failures will be assessed once the product becomes available for inspection.-clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate (b)(4) devices, including serial number (b)(6), were manufactured and accepted into final stock on 05/01/2020 with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the alleged failure mode was not confirmed because the product was not available for inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.

• Brand Name: HANDPIECE MICS
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 11412927
• MDR Text Key: 238595202
• Report Number: 3005985723-2021-00037
• 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: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 42040420
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/08/2021
• Initial Date FDA Received: 03/04/2021
• Supplement Dates Manufacturer Received: 05/03/2021
• Supplement Dates FDA Received: 05/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other