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

Model Number	AF01R
Medical Device Problem Codes	Material Puncture/Hole (1504); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report confirmed.Evaluation determined that the leg was bent.It was also noted that the color band was faded.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 25 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 no reported malfunction.No patient impact reported.Upon analysis it was noted that the leg was bent.On follow-up, it was confirmed that the event occurred during a craniotomy procedure, and there was no impact or issues with the patient post-surgery.It was also reported that there was no delay in the procedure, no additional actions required, and a backup device was used to complete the surgery.

• 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: 10731111
• Report Number: 1625507-2020-00196
• Device Sequence Number: 16909305
• Product Code: HBB
• UDI-Device Identifier: 00613994469151
• UDI-Public: 00613994469151
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/23/2020

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: AF01R
• Device Catalogue Number: AF01R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 10/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1