MAUDE Adverse Event Report: MAKO SURGICAL CORP. MAKOPLASTY® PARTIAL KNEE END EFFECTOR; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 111758

Device Problems Electrical /Electronic Property Problem (1198); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 07/24/2017

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

Power kept shutting off.Discovered the anspach was pulling out of the hand piece and would not stay in.Case type: pka.Surgical delay: 30 minutes.

Manufacturer Narrative

Reported event: event reported that the anspach motor slipped out from a pka end effector.A 30 minute delay occurred.Device evaluation and results: functional inspection: an anspach motor, hd long attachment and burr were assembled to the device.The motor was run and the burr spun.No issue was found.The assembly remained intact.Device history review: review of device history records show (b)(4) devices were accepted into final stock on 08/18/2016 with no reported discrepancies.Complaint history review: review of complaints within the trackwise database for p/n 111758, l/n 19480615 show (b)(4) complaints related to the alleged failure.The pr numbers are (b)(4).Conclusion: the failure mode was not confirmed.No issue was found.Corrective action / preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.

Event Description

Power kept shutting off.Discovered the anspach was pulling out of the hand piece and would not stay in.Case type: pka.Surgical delay: 30 minutes.

• Brand Name: MAKOPLASTY® PARTIAL KNEE END EFFECTOR
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: bethany hinson ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 6768612
• MDR Text Key: 81932134
• Report Number: 3005985723-2017-00356
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112507
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/23/2017

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: 111758
• Device Lot Number: 19480615
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/24/2017
• Initial Date FDA Received: 08/04/2017
• Supplement Dates Manufacturer Received: 10/18/2017
• Supplement Dates FDA Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization