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

Model Number 209063

Device Problems Residue After Decontamination (2325); Separation Failure (2547)

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

Event Date 03/05/2020

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

Bearings inside attachment contain black substance and do not seem to be functioning properly.The attachments are difficult to remove from the attachment.Case type: tka.

Event Description

Bearings inside attachment contain black substance and do not seem to be functioning properly.The attachments are difficult to remove from the attachment.Case type: tka.

Manufacturer Narrative

Reported issue: bearings inside attachment contain black substance and do not seem to be functioning properly.The attachments are difficult to remove from the attachment.Case type: tka.Product inspection: product was not inspected as the product was not returned for evaluation.Device history review: device history records indicate 25 devices were manufactured under prodex lot k08kv and 23 devices were accepted into final stock on 11/15/2016.A review 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 42011016 shows no additional complaints related to the failure in this investigation.Conclusion: the alleged failure mode could not be confirmed as 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: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9883850
• MDR Text Key: 185075382
• Report Number: 3005985723-2020-00183
• 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: 05/14/2020

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: 4201229
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/05/2020
• Initial Date FDA Received: 03/26/2020
• Supplement Dates Manufacturer Received: 05/12/2020
• Supplement Dates FDA Received: 05/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other