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

Model Number AF02

Device Problems Break (1069); Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Report confirmed.Evaluation determined that the foot was worn/scraped and the tip was missing.The device was tested and the temperature was measured to be 124.7°f.It was also noted that the device was noisy, the color ring and markings were deteriorated.Previous investigation performed under pr#127716 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 approximately 137 months with no record of factory service during this period.We will continue to track and trend this complaint type.If information is provided in the future, a supplemental report will be issued.

Event Description

Repair request initiated for device with the report of tip guard breakage.No patient impact reported.Repair escalated to product event due to analysis finding of foot was scraped and the tip was missing.On follow-up, it was confirmed that there was no patient or staff impact.

• Brand Name: MIDAS REX 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 gustafson ; 4620 north beach street; ft. worth, TX 76137-3291 ; 7635149628
• MDR Report Key: 12160994
• MDR Text Key: 263460401
• Report Number: 1625507-2021-00244
• Device Sequence Number: 1
• Product Code: HBB
• UDI-Device Identifier: 00721902481857
• UDI-Public: 00721902481857
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K020069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/13/2021

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 Expiration Date: 03/24/2015
• Device Model Number: AF02
• Device Catalogue Number: AF02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Initial Date Manufacturer Received: 12/25/2020
• Initial Date FDA Received: 07/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2009
• 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