MAUDE Adverse Event Report: MAKO SURGICAL CORP. SHELL IMPACTION PLATFORM; STEREOTACTIC DEVICE, ROBOTICS

Catalog Number 206270

Device Problems Mechanical Problem (1384); No Apparent Adverse Event (3189)

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

Event Date 01/24/2017

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

The surgeon was completing a total hip arthroplasty procedure using the robotic arm interactive orthopedic system (rio).The impaction platform cracked during cup impaction.

Manufacturer Narrative

Reported event: the event reported that a shell impaction platform cracked during use.No harm occurred.Per communication logs, additional inspection of the device was performed after the initial complaint and no issue was found.The part will be not be returned.Device evaluation and results: unable to perform as the device was not returned.Per communication logs, additional inspection of the device was performed after the initial complaint and no issue was found.The part will be not be returned.Device history review: review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock on 02/13/2013 via npr (b)(4).Complaint history review: a review of complaint for p/n 206270, l/n dm010812 shows no complaints related to the alleged failure.Conclusion: the investigation concluded that no device failure occurred.Per communication logs, additional inspection of the device was performed after the initial complaint and no issue was found.The part will be not be returned.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.Device not returned to manufacturer.

Event Description

The surgeon was completing a total hip arthroplasty procedure using the robotic arm interactive orthopedic system (rio).The impaction platform cracked during cup impaction.

• Brand Name: SHELL IMPACTION PLATFORM
• 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: michael mcavenia ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 6285751
• MDR Text Key: 66046752
• Report Number: 3005985723-2017-00042
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141989
• 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: 04/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 206270
• Device Lot Number: DM010812
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/17/2017
• Was Device Evaluated by Manufacturer?: No
• 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