MAUDE Adverse Event Report: MEDTRONIC HUMACOA LEGEND DISSECTING TOOL; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Catalog Number 14MH30

Device Problem Positioning Problem (3009)

Patient Problem Laceration(s) (1946)

Event Date 03/17/2015

Event Type  Injury  

Event Description

It was reported by the sales representative that during a minimally invasive procedure the patient's dura was torn, requiring repair.The repair extended the length of the procedure by approximately one hour.There was no additional patient impact associated with the injury.The procedure was an l4-5 foraminotomy performed with a tube.The surgeon reported he was having difficulty visualizing the surgical field due to the relative size of the attachment and the surgical tube when the injury occurred.Upon follow-up it was reported the surgeon was unaware of any adverse outcomes for the patient post repair.It was confirmed the additional actions taken during the procedure involved a repair of the durotomy, and accessing a backup drill which included exchanging an electric motor for a competitor¿s pneumatic motor.Patient information was provided, and it was confirmed there was no staff impact.A medwatch report has not been filed by the hospital at this time; and the initial reporter information was provided.

Manufacturer Narrative

Report inconclusive.No evaluation could be 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 ¿employ visualization, including use of imaging techniques (e.G., fluoroscopy, image guided surgery) when using rotating powered accessories.Discontinue powered application in the event of lack of visualization of surgical site.¿ in addition, ¿midas rex variable exposure attachments: surgeons should familiarize themselves with the performance of dissecting tools before use, and should explore the effect of various levels of tool exposure on dissection stability.If the tool exhibits excessive chatter, vibration, or movement, decrease the tool exposure.¿ we will continue to monitor this complaint type for trends.(b)(4).

Manufacturer Narrative

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

• Brand Name: LEGEND DISSECTING TOOL
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): MEDTRONIC HUMACOA; puerto rico 909; humacao,pr 00791
• Manufacturer (Section G): MEDTRONIC POWERED SURGICAL SOLUTIONS; 4620 north beach street; ft. worth TX 76137 3291
• Manufacturer Contact: david leers ; 4620 north beach street; ft. worth, TX 76137-3291 ; 8177886587
• MDR Report Key: 4691149
• MDR Text Key: 16888729
• Report Number: 1030489-2015-00789
• Device Sequence Number: 1
• Product Code: HBE
• 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,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2020
• Device Catalogue Number: 14MH30
• Device Lot Number: H5166276
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/29/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN METRX TUBE
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 122