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

Catalog Number 209063

Device Problems Output Problem (3005); Non Reproducible Results (4029)

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

Event Date 05/21/2019

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

Mics didn't fire when trigger pulled for reaming, robot stated cable connection error.Went through full trouble shooting steps to resolve problem to no avail.Tried a second mics, same issue occurred.Ended up using a system 7 power to ream.After case, did full shut down and reboot and tested both mics, and both failed mics status check.Surgical delay: 5 minutes.Case completed robotically.Case type: tha.

Manufacturer Narrative

Reported event: it was reported that the mics didn't fire when trigger pulled for reaming, robot stated cable connection error.After the case, a full shut down and reboot was carried out, and it failed mics status check.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 25 devices were manufactured under lot k0as6 and all 25 devices were accepted into final stock on 2/9/2018 with no relevant discrepancies.Complaint history review a review of complaints in catsweb and trackwise related to p/n 209063, prodex lot k0as6 shows 03 additional complaints related to the failure in this investigation.The complaint is pr (b)(4).Conclusions: the failure could not be determined 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.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated that nc 1414517 and capa 1450904 are associated with the failure mode reported in this event.

Event Description

Mics didn't fire when trigger pulled for reaming, robot stated cable connection error.Went through full trouble shooting steps to resolve problem to no avail.Tried a second mics, same issue occurred.Ended up using a system 7 power to ream.After case, did full shut down and reboot and tested both mics, and both failed mics status check.Surgical delay: 5 minutes.Case completed robotically.Case type: tha.

• 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: 8681141
• MDR Text Key: 147518543
• Report Number: 3005985723-2019-00415
• 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: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• 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: 42030118 / 4203466
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization