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

Model Number AF02R

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 attachment was damaged.The likely cause was identified as leg is worn and foot is chipped.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.If damage is found, the device should not be used.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 broken.It was reported that there was no patient involvement.Repair escalated to a product event due to evaluation finding of chipped foot.

• Brand Name: MIDAS REX® LEGEND 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: glen belmer ; 7000 central avenue ne; ft. worth, TX 76137-3291 ; 6122713209
• MDR Report Key: 13435707
• MDR Text Key: 286759495
• Report Number: 1625507-2022-00015
• Device Sequence Number: 1
• Product Code: HBB
• UDI-Device Identifier: 00613994469168
• UDI-Public: 00613994469168
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K020069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/02/2022

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: AF02R
• Device Catalogue Number: AF02R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2022
• Initial Date FDA Received: 02/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2015
• 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