MAUDE Adverse Event Report: MAKO SURGICAL CORP. DUAL PIN BASE CLAMP ASSEMBLY; STEREOTACTIC DEVICE, ROBOTICS

Catalog Number 111430

Device Problems Mechanical Problem (1384); Device Dislodged or Dislocated (2923)

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

Event Date 01/25/2017

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

The surgeon was performing a partial knee arthroplasty procedure using the robotic arm interactive orthopedic system (rio) when the mako array clamp part# (b)(4) broke off pin clamp part# (b)(4) prior to incision.A second set was opened and that pin clamp assembly was utilized.Case proceeded without incident.

Manufacturer Narrative

Reported event: the reported device is a dual pin base clamp assembly, catalog # 111430, lot #19220411 which broke during a case allowing the tibial array to become separated from the bone pin clamp.Device evaluation and results: visual inspection: visual inspection shows that the end of the clamp which should have the female thread for mounting the array clamp has broken off.Dimensional inspection: dimensional inspection was not completed as the visual inspection is sufficient to confirm the failure mode.Functional inspection: without the threaded end of the clamp; the array clamps cannot be secured to the bone pins.Device history review: a review of the device history record shows that (b)(4) parts were manufactured and accepted into stock on 10/4/11.Complaint history review: based on the device identification the complaint databases were reviewed from 2011 to present for similar reported events regarding a broken dual pin base clamp assembly.There has been no other event for the lot number referenced, however, there are 3 events for the part: (b)(4).Conclusions: the report of a broken 111430 bone pin clamp was not confirmed.The cause of the failure cannot be determined as the component which broke was not returned.The failure occurred during a case and caused a delay, however, the case was successful.Corrective action/preventive action: no further action is required.

Event Description

The surgeon was performing a partial knee arthroplasty procedure using the robotic arm interactive orthopedic system (rio) when the mako array clamp part# 112100 broke off pin clamp part# 111430 prior to incision.A second set was opened and that pin clamp assembly was utilized.Case proceeded without incident.

Manufacturer Narrative

Follow up# 2 is being submitted to correct the catalog number and the lot number.The discrepancy was found on 10/25/2017.

Event Description

The surgeon was performing a partial knee arthroplasty procedure using the robotic arm interactive orthopedic system (rio) when the mako array clamp part# 112100 broke off pin clamp part# 111430 prior to incision.A second set was opened and that pin clamp assembly was utilized.Case proceeded without incident.

• Brand Name: DUAL PIN BASE CLAMP ASSEMBLY
• 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: bethany hinson ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 6293945
• MDR Text Key: 66274705
• Report Number: 3005985723-2017-00045
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 111430
• Device Lot Number: 19210411
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2017
• 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