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

Model Number PM100

Device Problem Vibration (1674)

Patient Problem Nerve Damage (1979)

Event Date 10/21/2010

Event Type  Injury  

Event Description

Lawsuit alleges: ¿¿on (b)(6) 2010 (surgeon) performed a l3-l5 decompressive laminectomy on (patient) utilizing a high speed-pneumatic drill.During the procedure (patient) suffered a dural tear, caused by the drill contacting the dura.(patient's) medical records demonstrate neither (surgeon) identified, separated or removed any scar tissue around the dura resulting from (patient) previous laminectomy¿also that there was not any type of hard instrument placed between the drill and the dura to prevent (patient) injury.¿the standard of care when using a high speed pneumatic drill was not meet as the dura was not properly identified.(patient) has incurred general damages in form of past and present physical and emotional pain and suffering and will incur additional general damages in the form of future physical and emotional pain and suffering¿¿.

Manufacturer Narrative

Notice of a lawsuit was received alleging a dural tear occurred during use of a high-speed pneumatic.Because the serial number of the device could not be identified, no evaluation or review of device history records could be performed.Motor type was inferred through review of shipment records, but was unable to be confirmed.There was no allegation of malfunction of the drill.The user manual contains the following statement under general operating guidelines: ¿the legend system is designed for use by medical professionals familiar with powered surgical instrumentation.¿ (b)(4).

Manufacturer Narrative

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

• Brand Name: LEGEND GOLD
• Type of Device: MOTOR, DRILL, PNEUMATIC
• Manufacturer (Section D): MDT POWERED SURGICAL SOLUTIONS; 4620 n beach st; fort worth TX 76137
• 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: 3884869
• MDR Text Key: 4648903
• Report Number: 1625507-2014-00036
• Device Sequence Number: 1
• Product Code: HBB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 05/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PM100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/22/2014
• 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
• Treatment: UNKNOWN TOOL, UNKNOWN ATTACHMENT
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 00059 YR