MAUDE Adverse Event Report: MAKO SURGICAL CORP. ANSPACH HD LONG ATTACHMENT; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 110920

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

Patient Problems Burn(s) (1757); No Known Impact Or Consequence To Patient (2692)

Event Date 04/24/2017

Event Type  Injury  

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 partial knee arthroplasty procedure using the robotic arm interactive orthopedic system.The long hd sounded high pitch during burring and heated up enough to burn the surgeon's finger.

Manufacturer Narrative

Reported event: the event reported that an anspach hd long attachment loud noise during burring and overheating occurred burning the surgeon's finger.A delay of 10 minutes occurred.Device evaluation and results: the anspach hd long attachment was bench evaluated using a known good anspach motor, anspach foot switch, burr tool and anspach console and all testing successful and the error could not be duplicated.No overheating or audible noise occurred.Device history review: not performed as the anspach hd long attachment is an oem product.Complaint history review: review of complaints for p/n 110920, s/n (b)(4) showed no other complaints within the trackwise database.Conclusion: the failure could not be duplicated.The overheating of the hd long attachment could be due to the anspach motor overheating and transferring thermal energy to the hd long attachment.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 was completing a partial knee arthroplasty procedure using the robotic arm interactive orthopedic system.The long hd sounded high pitch during burring and heated up enough to burn the surgeon's finger.

• Brand Name: ANSPACH HD LONG ATTACHMENT
• 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: michael mcavenia ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 6522055
• MDR Text Key: 73694035
• Report Number: 3005985723-2017-00195
• 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: 06/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 110920
• Device Lot Number: SNF44307062101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/18/2017
• 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): Other