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

Catalog Number 209063

Device Problems Electrical Power Problem (2925); Power Problem (3010)

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

Event Date 08/01/2019

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 stopped cutting during surgery (lost power) had to replace.Case type: tka.Surgical delay: 30 minutes.

Manufacturer Narrative

Follow-up #1 and final report submitted.Reported event: mics stopped cutting during surgery (lost power) had to replace.Product evaluation and results: functional inspection was performed and confirmed that the power kept shutting off when the blade wasn't even on the bone.Attempts to repair were unsuccessful.Rtv reason: missing screw in collar.Visual inspection, dimensional inspection and material analysis.Analysis were not performed as functional inspection confirmed the failure.Per (b)(4).Part was rtv for rework.Product history review: device history records indicate 25 devices were manufactured under lot: k08bv and 24 devices were accepted into final stock on 9/15/16.A review of qt16-09-0053 revealed that the issue is not related to the failure alleged in this compliant.Complaint history review: a review of complaints related to p/n: 209063, prodex lot: k08bv shows 03 additional complaint(s) related to the failure in this investigation.Complaint: (b)(4).Conclusions: the alleged failure mode was confirmed.No additional investigation or specific actions are required.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 stopped cutting during surgery (lost power) had to replace.Case type: tka.Surgical delay: 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: 8871213
• MDR Text Key: 155696094
• Report Number: 3005985723-2019-00566
• 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: 09/29/2019

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 Catalogue Number: 209063
• Device Lot Number: 42040816 / 4201068
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/01/2019
• Initial Date FDA Received: 08/07/2019
• Supplement Dates Manufacturer Received: 09/27/2019
• Supplement Dates FDA Received: 09/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization