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

Model Number AF02

Device Problem Device Abrasion From Instrument Or Another Object (1387)

Patient Problem No Patient Involvement (2645)

Event Date 06/07/2016

Event Type  malfunction  

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.Previous investigation performed under pr# (b)(4) determined that the likely causes are debris in the collet and improper insertion of the tool.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 monitor this complaint type for trends.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Repair request initiated for device with the report of foot detached.It was reported there was no patient or staff impact.Repair request escalated to product event based upon reason for return.On follow up the scrub technician confirmed the damage to the attachment did not occur during the craniotomy procedure, but had been damaged during cleaning of the attachment postoperative.Although there was no patient involvement, patient information for the last procedure in which the attachment was used was provided.It was confirmed the patient was discharged from the hospital in good condition.Concomitant device information was unknown.

Manufacturer Narrative

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

• 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): MDT POWERED SURGICAL SOLUTIONS; 4620 n beach st; fort worth TX 76137
• Manufacturer Contact: david leers ; 4620 north beach street; ft. worth, TX 76137-3291 ; 8177886587
• MDR Report Key: 5771948
• MDR Text Key: 48838215
• Report Number: 1625507-2016-00027
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 06/13/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/08/2016
• Initial Date FDA Received: 07/06/2016
• Supplement Dates Manufacturer Received: 06/08/2016
• Supplement Dates FDA Received: 09/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2011
• 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 Age: 62 YR
• Patient Weight: 92