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

Model Number 209063

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

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

Event Date 12/12/2019

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

During straight saw cuts, the handpiece became extremely loud, upon a difficult removal of the attachment there was a dark oil substance inside of the handpiece.Case type: tka.

Event Description

During straight saw cuts, the handpiece became extremely loud, upon a difficult removal of the attachment there was a dark oil substance inside of the handpiece.Case type: tka.

Manufacturer Narrative

Reported issue during straight saw cuts, the handpiece became extremely loud, upon a difficult removal of the attachment there was a dark oil substance inside of the handpiece.Case type: tka.Product inspection product was not inspected as the product was not returned for evaluation.Device history review review of device history record indicate that 25 devices were manufactured under prodex lot k0dc1 and 25 accepted into final stock on 09/13/2019.No non-conformance was identified in the process.Complaint history review a review of complaints in catsweb and trackwise related to p/n 209063, lot number42050819 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.Nc/capa review a review of stryker¿s nc/capa database indicated there have been an nc and capa associated with the product and failure mode reported in this event.This is nc 1414517 and capa 1450904.H3 other text : device not returned.

• 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: 9559291
• MDR Text Key: 175047235
• Report Number: 3005985723-2020-00004
• 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: 03/26/2020

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: 42050819
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/12/2019
• Initial Date FDA Received: 01/07/2020
• Supplement Dates Manufacturer Received: 03/08/2020
• Supplement Dates FDA Received: 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other