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

Model Number	AF02R
Medical Device Problem Codes	Material Puncture/Hole (1504); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report confirmed.Evaluation determined that the foot was detached.It was also noted that the attachment was worn, the front hole was enlarged, and there was tool removal difficulty.Previous investigation performed under pr# (b)(4) determined that the likely causes are debris in the collet and improper insertion of the tool.The device user manual warnings section includes instructions to check the device for damage before use.If damage is found, the device should not be used.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 41 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 or Problem Description
Repair request initiated for device with the report of tool got stuck.It was reported that there was no patient involvement.Repair escalated to product event on evaluation due to foot found detached.

• Brand Name: MIDAS REX LEGEND FOOTED ATTACHMENT
• Common Device Name: MOTOR, DRILL, PNEUMATIC
• Manufacturer (Section D): MDT POWERED SURGICAL SOLUTIONS; 4620 n beach st; fort worth TX 76137
• MDR Report Key: 12418684
• Report Number: 1625507-2021-00300
• Device Sequence Number: 3457615
• Product Code: HBB
• UDI-Device Identifier: 00613994469168
• UDI-Public: 00613994469168
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K020069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2021

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
• Operator of Device: Health Professional
• Device Model Number: AF02R
• Device Catalogue Number: AF02R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 09/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1