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

Catalog Number 209063

Device Problems Computer Software Problem (1112); Electrical /Electronic Property Problem (1198); Power Problem (3010); Complete Loss of Power (4015)

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

Event Date 07/22/2019

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 did not pass status check after having to replace previous mics mid case.Case type: pka surgical delay: 30 minutes.

Event Description

Mics did not pass status check after having to replace previous mics mid case.Case type: pka.Surgical delay: 30 minutes.

Manufacturer Narrative

Reported event: it was reported that mics did not pass status check after having to replace previous mics mid case.Product evaluation and results: "as per service maxwo-02010721 & case number (b)(4).Rma# 271018.Sn# (b)(4).Factory service technician: (b)(4): 1.Unable to repair mics as with the new cable did not fix the issue.Disposition (return to vendor).Other (rtv) reason: failed collar test.The alleged failure was confirmed".Product history review: device history records indicate (b)(4) were manufactured under lot k0671 and all 25 devices were accepted into final stock on 11/10/2015.No non-conformance were identified during inspection.Complaint history review: a review of complaints related to p/n 209063, prodex lot k0671 shows 07 additional complaint(s) related to the failure in this investigation.Complaint (b)(4).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 nc (b)(4) and capa 1450904.

• 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: 8864792
• MDR Text Key: 155703873
• Report Number: 3005985723-2019-00557
• 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: 11/15/2019

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: 42031015 / 4200304
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/22/2019
• Initial Date FDA Received: 08/06/2019
• Supplement Dates Manufacturer Received: 10/25/2019
• Supplement Dates FDA Received: 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization