MAUDE Adverse Event Report: MDT POWERED SURGICAL SOLUTIONS LEGEND DISSECTING TOOL; MOTOR, DRILL, PNEUMATIC

Model Number PSS UNKNOWN TOOL

Device Problem Metal Shedding Debris (1804)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/01/2017

Event Type  Injury  

Manufacturer Narrative

No conclusion can be drawn.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 warning ¿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.¿ we will continue to track and trend this complaint type.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a post-operative mri scan, there was an artifact that was found in the patient's body on the scan.No patient impact reported.On follow up with the physician, it was reported that this type of event occurred several times over the past year.However, he had no additional information regarding the dates of the events.It was reported the tools that were being used during the procedures were either m8 cutting burr or diamond burr tools.It was also reported by the physician that there was no damage to the tools when the events occurred.On further follow up, it was reported by the facility the situation they faced was what looked like metal debris on post op mri scans on patients who had undergone posterior fossa decompressive procedures for chiari i abnormality.This type of event was limited to those patients who had an external decompression with durotomy with posterolateral foramen magnum decompression using either the m8 cutting or diamond burr under the microscope.In an effort to prevent dural disruption, a metal instrument such as a #2 currette or a penfield 3 was placed underneath the bone between the dura over the lateral medulla and the bone itself.The facility believes that the debris was created due to the drill touching the metal instrument.The user facility has changed their operative technique to avoid using any instrument underneath the drill.It was also reported that the physician has used the drills in other situations and has had no problems.

• Brand Name: LEGEND DISSECTING TOOL
• 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: 7158676
• MDR Text Key: 96207885
• Report Number: 1625507-2018-00001
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PSS UNKNOWN TOOL
• Device Catalogue Number: PSS UNKNOWN TOOL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other