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

Catalog Number 111758

Device Problems Detachment Of Device Component (1104); Material Separation (1562)

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

Event Date 05/05/2016

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

The surgeon performed a partial knee arthroplasty using the robotic arm interactive orthopedic system (rio).During the case, the magnet from the end effector fell off.This did not affect the case or the patient.Another instrument was used and the breakage did not affect the outcome of the case which was successful.

Manufacturer Narrative

Reported event: the event reported that the magnet of a partial knee end effector was missing.The failure was noticed during a cadaver lab and not associated with a case or patient.Device history review: review of device history records indicate (b)(4) devices on 11/24/15, (b)(4) devices on 11/25/15, (b)(4) devices on 12/03/15, (b)(4) devices on 12/07/15, and (b)(4) devices on 12/10/15 were accepted into final stock.The one device (s/n (b)(4)) was rejected for no bead blast performed and disposition was (b)(4).The non-conformance was not related to the alleged failure investigation and did not affect the failed device.Device evaluation and results: -visual inspection: the magnet was missing.No signs of residue was seen.-dimensional inspection: visual inspection confirmed the failure.-functional inspection: visual inspection confirmed the failure.Complaint history review: review of complaints within the trackwise database based on p/n 111758, l/n 19320515 show (b)(4) complaints related to the alleged failure in this complaint.(b)(4).Tracking of complaints related to p/n 111758 will be tracked through (b)(4).Conclusions: the failure was confirmed that the trigger magnet was missing from the device.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

The surgeon performed a partial knee arthroplasty using the robotic arm interactive orthopedic system (rio).During the case, the magnet from the end effector fell off.This did not affect the case or the patient.Another instrument was used and the breakage did not affect the outcome of the case which was successful.

• Brand Name: MAKOPLASTY® PARTIAL KNEE END EFFECTOR
• Type of Device: STEREOTACTIC 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: liza gordillo ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 5644305
• MDR Text Key: 44853799
• Report Number: 3005985723-2016-00152
• 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: 05/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 111758
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/26/2016
• 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): Other