MAUDE Adverse Event Report: MDT POWERED SURGICAL SOLUTIONS MIDAS REX® LEGEND FOOTED ATTACHMENT; MOTOR, DRILL, PNEUMATIC

Model Number AF02

Device Problem Material Puncture/Hole (1504)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/12/2018

Event Type  Injury  

Manufacturer Narrative

Report inconclusive.No evaluation was performed, as the device was not returned.If the device is returned in the future, product analysis may be performed.The user manual contains the following warnings ¿do not use a legend attachment if any part of the attachment appears to be bent, loose, missing or damaged.Do not use excessive pressure, such as bending or prying, on attachments or dissecting tools.This may cause tool to bend or break and cause injury to patient, operator and/or operating room staff." in addition, ¿insert dissecting tool into motor collet with a slight rotational motion.A tactile and audible click is observed indicating that the dissecting tool is fully seated.¿ we will continue to track and trend this complaint type.(b)(6).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a procedure, the footplate of the attachment broke off in the patient.The patient's condition was unknown at the time of the initial report but it was reported that a revision surgery was planned.The hospital has not returned the device and the serial number of the device was not provided.On follow up, it was confirmed that the initial procedure was completed with no other non-routine activities, and patient is clinically fine and continuing follow up post-surgery with the surgeon.It was also confirmed that the revision surgery has not been scheduled yet.Additional information about the event is currently being followed up for further details.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Upon further follow up, it was reported that the revision surgery proceeded as planned and the broken piece was removed on (b)(6) 2019.It was confirmed with the surgeon that there were no complications and the patient is now recovering from the procedure.The facility still has the attachment and no additional information about the availability for return was provided.

• Brand Name: MIDAS REX® LEGEND FOOTED ATTACHMENT
• Type of Device: MOTOR, DRILL, PNEUMATIC
• Manufacturer (Section D): MDT POWERED SURGICAL SOLUTIONS; 4620 n beach st; fort worth TX 76137
• Manufacturer (Section G): MDT POWERED SURGICAL SOLUTIONS; 4620 n beach st; fort worth TX 76137
• Manufacturer Contact: tricha miles ; 4620 north beach street; ft. worth, TX 76137-3291 ; 9496801224
• MDR Report Key: 8334943
• MDR Text Key: 136001052
• Report Number: 1625507-2019-00010
• Device Sequence Number: 1
• Product Code: HBB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AF02
• Device Catalogue Number: AF02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2019
• 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): Other
• Patient Weight: 83