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

Model Number	AF02R-R
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Twisted/Bent (2981); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Repair request initiated for device with no reported malfunction.No patient impact reported.Repair escalated to product event on evaluation due to leg of the footed attachment was bent.On follow up, no additional information was provided about the event.Date of event notification 09-jun-2022.
Additional Manufacturer Narrative
Evaluation determined that leg of the footed attachment was bent.The likely cause of failure is inadequate preventative maintenance.It was also noted that leg is misaligned and internal tube bearings, spacer bearings, nut and internal tube are missing.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
• 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: 15623127
• Report Number: 1625507-2022-00235
• Device Sequence Number: 17757581
• Product Code: HBB
• UDI-Device Identifier: 00613994448026
• UDI-Public: 00613994448026
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 10/18/2022

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
• Operator of Device: Health Professional
• Device Model Number: AF02R-R
• Device Catalogue Number: AF02R-R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2022
• Initial Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown