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

Model Number	AF01-R
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report confirmed.Evaluation determined that the foot of the attachment was broken off.The likely cause of failure is inadequate preventative maintenance.It was also noted color band and laser markings were illegible / faded.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 maximum specified service interval is 24 months.Device has been in used with no record of factory service during this period.We will continue to track and trend this complaint type.(b)(6).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 burr guard was broken off.It was reported that there was no patient involvement.Repair request escalated to a product event based on reason for return.
Additional Manufacturer Narrative
It was also noted that internal tube bearing was corroded.If information is provided in the future, a supplemental report will be issued.

• 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: 8239264
• Report Number: 1625507-2019-00002
• Device Sequence Number: 2280353
• Product Code: HBB
• UDI-Device Identifier: 00613994422217
• UDI-Public: 00613994422217
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 01/25/2019

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: AF01-R
• Device Catalogue Number: AF01-R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018
• Initial Date Received by Manufacturer: 12/17/2018
• Supplement Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 01/11/2019
• Supplement Report FDA Received Date: 01/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1