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

Catalog Number 209063

Device Problems Power Problem (3010); Non Reproducible Results (4029)

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

Event Date 02/07/2019

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 a mako tka with mr (b)(6) at (b)(6) hospital, following successful rio registration, robot was brought in to commence bone resection.A cable connection error occurred.Cutter reset, misc disconnected and reconnected.Error message continued and no power to the misc handpiece.Handpiece replaced, rio registration completed again.Surgical cuts were undertaken and case completed successfully.20 minute surgical delay.

Manufacturer Narrative

Follow-up #1 and final report submitted.Reported event: during a mako tka with mr (b)(6) at (b)(6) hospital, following successful rio registration, robot was brought in to commence bone resection.A cable connection error occurred.Cutter reset, misc disconnected and reconnected.Error message continued and no power to the misc handpiece.Handpiece replaced, rio registration completed again.Surgical cuts were undertaken and case completed successfully.20 minute surgical delay.Product evaluation and results: the product was unavailable for inspection as the product was not returned.Product history review: device history records indicate 25 devices were manufactured under lot k0bej and all units were accepted into final stock on 6/26/18.No non-conformances were identified during inspection.Complaint history review: a review of complaints related to p/n 209063, prodex lot k0bej shows 02 additional complaint(s) related to the failure in this investigation.Complaint (b)(4).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 there have been an nc and capa associated with the product and failure mode reported in this event.This is nc1414517 and capa 1450904.Device not returned.

Event Description

During a mako tka with mr (b)(6) at (b)(6) hospital, following successful rio registration, robot was brought in to commence bone resection.A cable connection error occurred.Cutter reset, misc disconnected and reconnected.Error message continued and no power to the misc handpiece.Handpiece replaced, rio registration completed again.Surgical cuts were undertaken and case completed successfully.20 minute surgical delay.

• 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: 8351869
• MDR Text Key: 136613985
• Report Number: 3005985723-2019-00158
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2019
• 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: 42030618 SN-4204258 1
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization