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 09/28/2016

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 (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.¿ the preventive maintenance/service manual for the legend system specifies service intervals for devices based on the hospital usage level.The maximum specified service interval is 24 months.Device has been in use for greater than 96 months with no record of factory service during this period.We will continue to monitor this complaint type for trends.

Event Description

Repair request initiated for device with the report of footed portion being damaged by tool contact.It was reported there was no patient involvement, and the device damage was identified during set up prior to use.Repair request escalated to a product event based on reason for return.On follow up, it was reported there were no additional or non-routine actions taken as a result of the damage.A back up device was used with no delay in the procedure.The name of the initial reporter was provided.

• 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: 6089882
• MDR Text Key: 59512339
• Report Number: 1625507-2016-00042
• 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: Nurse
• Type of Report: Initial
• Report Date: 10/11/2016

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: 10/11/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2016
• Initial Date FDA Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2005
• 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