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

Model Number AF02

Device Problem Material Fragmentation (1261)

Patient Problems Hemorrhage, Subdural (1894); Tissue Damage (2104)

Event Date 06/25/2015

Event Type  Injury  

Event Description

Repair request initiated for device with the report of attachment foot fracture.It was reported that there was no patient impact.Report escalated to product event based on reason for return.On follow up it was reported that a backup device was used to complete the procedure, and there was about twenty minutes delay.During the delay it was reported there was dura mater damage, and cerebral surface right contusion and hemorrhage.The surgeon did not think the injury was caused by the device, but rather was a normal symptom during the resection of the left occipital glioma.In addition, the patient was reported as well postoperative, and subsequently discharged from the hospital.

Manufacturer Narrative

Report confirmed.Evaluation determined that the footed portion was damaged by tool contact.A portion of the foot of the attachment was detached and missing.Evaluation of the photograph shows the breakage of the footed portion of the attachment is consistent with prying with the device while sawing of the bone plate was being performed.It also does not appear that the tool perforated the foot plate.The user manual contains the following warning ¿the attachment should not be used if any part of the attachment appears to be bent, loose, missing, or damaged.Excessive pressure or improper handling, such as bending or prying, of the attachment or dissecting tool may cause injury to the patient, operator and/or operating room staff." in addition, ¿a tactile and audible click will be observed when attachment is fully seated.Tactile feedback is felt when the dissecting tool is fully seated.Turn the tool locking ring to the ¿lock¿ position.Verify that the tool is in place by gently pulling on the tool.¿ we will continue to monitor this complaint type for trends.(b)(4).

• Brand Name: 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): MEDTRONIC POWERED SURGICAL SOLUTIONS; 4620 north beach street; ft. worth TX 76137 329
• Manufacturer Contact: david leers ; 4620 north beach street; ft. worth, TX 76137-3291 ; 8177886587
• MDR Report Key: 4943157
• MDR Text Key: 6254714
• Report Number: 1625507-2015-00038
• Device Sequence Number: 1
• Product Code: HBB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K020069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2015
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2014
• 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: EM100-A, S/N (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 00043 YR
• Patient Weight: 75