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

Model Number AF02R

Device Problems Break (1069); Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2020

Event Type  malfunction  

Manufacturer Narrative

Report confirmed.Evaluation determined that the portion of the footed attachment was cut.It was also noted that the color band is illegible.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.¿ we will continue to track and trend this complaint type.Phone number: (b)(6) if information is provided in the future, a supplemental report will be issued.

Event Description

Repair request initiated for device with the report of broken.It was reported that there was no patient impact.It was noted during decontamination that the foot was cut.On follow up, no further information can be provided about the event and the status of the patient post-surgery.

• Brand Name: MIDAS REX LEGEND FOOTED ATTACHMENT
• Type of Device: 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: tricha miles ; 4620 north beach street; ft. worth, TX 76137-3291 ; 7635140379
• MDR Report Key: 10525641
• MDR Text Key: 227639162
• Report Number: 1625507-2020-00152
• Device Sequence Number: 1
• Product Code: HBB
• UDI-Device Identifier: 00613994469168
• UDI-Public: 00613994469168
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/11/2020

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
• Device Operator: Health Professional
• Device Model Number: AF02R
• Device Catalogue Number: AF02R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2020
• Initial Date FDA Received: 09/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1