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

Catalog Number 209063

Device Problems Mechanical Jam (2983); Non Reproducible Results (4029)

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

Event Date 12/10/2018

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

Event description: during reaming trigger on mics handpiece was getting stuck.Case type: tha.Mps stated is not sure if the mics continued to run while outside of the stereotactic boundary."wwe" freed the arm to cut off power before the surgeon took it out of the stereotactic boundary.

Manufacturer Narrative

Follow-up #1 and final report submitted to update sections d.3, g.1, g.4, g.7, h.2, h.3, h.6, h.10 and h.11 based on the results of investigation.Reported event: it was reported that during reaming trigger on mics hand piece was getting stuck.Product evaluation and results: product inspection could not be performed as the product was not available for evaluation.Product history review: device history records indicate (b)(4) devices were manufactured under lot k06ny and accepted into final stock on 3/22/2016.No non-conformances were identified during inspection.Complaint history review: a review of complaints related to p/n 209063, prodex lot k06ny shows no additional complaint(s) related to the failure in this investigation.Conclusions: the failure mode could not be confirmed because the part was not available for evaluation.If device and/or additional information become available, this investigation will be reopened.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated that there have been no nc and capa are associated with the failure mode reported in this event.

Event Description

Event description: during reaming trigger on mics handpiece was getting stuck case type: tha.Mps stated is not sure if the mics continued to run while outside of the stereotactic boundary.Wwe freed the arm to cut off power before the surgeon took it out of the stereotactic boundary.

• 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: 8205136
• MDR Text Key: 131925355
• Report Number: 3005985723-2018-00803
• 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: 04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 209063
• Device Lot Number: 42020116/4200470
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization