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

Model Number	AF02R-R
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report confirmed.Evaluation determined that a portion of the foot of the attachment was perforated.It was also noted the internal tube bearings were corroded.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Upon follow up, it was confirmed that there was no patient impact and the defect was detected prior to the surgery.
Additional Manufacturer Narrative
Report inconclusive.The device has been returned and still has pending evaluation results.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 attachmentsor 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.¿ we will continue to track and trend this complaint type.Initial reporter: telephone number (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 a bent foot.No patient impact reported.Repair escalated to product event due to decontamination finding of a cut foot.Additional information is being requested regarding patient impact.

• 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: 9084565
• Report Number: 1625507-2019-00099
• Device Sequence Number: 16799931
• Product Code: HBB
• UDI-Device Identifier: 00613994448026
• UDI-Public: 00613994448026
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K020069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2019

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: AF02R-R
• Device Catalogue Number: AF02R-R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 09/18/2019
• Supplement Report FDA Received Date: 10/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1