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

Catalog Number 209063

Device Problems Mechanical Problem (1384); Power Problem (3010)

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

Event Date 04/23/2019

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

Mics power unit failed on anterior chamfer cut.The power was present though the saw was not working, we checked the saw attachment and found there were no issues.There continued to be no movement to the saw blade through the saw attachment even when the surgeon had entered the haptics.There was nothing else that could be done except replace the mics to complete the surgery.Case type: tka.Surgical delay: 16-30 minutes.

Manufacturer Narrative

Reported event: it was reported that mics power unit failed on anterior chamfer cut.The power was present though the saw was not working, we checked the saw attachment and found there were no issues.There continued to be no movement to the saw blade through the saw attachment even when the surgeon had entered the haptics.There was nothing else that could be done except replace the mics to complete the surgery.Product evaluation and results: as per work order wo-01636046 and case number 03545944 the alleged failure mode was confirmed."1.Unable to repair mics as with the new cable did not fix the issue.Disposition - (return to vendor) rtv reason: broken collar" product history review: review of the product history records indicate 25 devices were manufactured under lot no k0c5d and 23 devices were accepted into final stock on 12/10/2018.Review of qt18- 12 - 0030 revealed that the non-conformance 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 (b)(4) , lot number k0c5d shows no additional complaints related to the failure in this investigation.Conclusions: the alleged failure mode was confirmed.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.

Event Description

Mics power unit failed on anterior chamfer cut.The power was present though the saw was not working, we checked the saw attachment and found there were no issues.There continued to be no movement to the saw blade through the saw attachment even when the surgeon had entered the haptics.There was nothing else that could be done except replace the mics to complete the surgery.Case type: tka.Surgical delay: 16-30 minutes.

• 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: 8594658
• MDR Text Key: 144561392
• Report Number: 3005985723-2019-00351
• 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: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• 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: 42061118 / 4205427
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization