MAUDE Adverse Event Report: MDT POWERED SURGICAL SOLUTIONS ATT MR8 ANGLED STRAIGHT; MOTOR, DRILL, ELECTRIC

Model Number MR8-AS10-R

Device Problems Overheating of Device (1437); Vibration (1674); Naturally Worn (2988)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/11/2022

Event Type  malfunction  

Manufacturer Narrative

Report confirmed.The device was tested and the temperature was exceeding 135°f.The likely cause was identified as chattered and corroded bearings.It was also noted that stem wont go through due to presence of foreign debris in the tube internal.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.If information is provided in the future, a supplemental report will be issued.

Event Description

Repair request initiated for device with the report of bearings chatter.It was reported that there was no patient or staff impact.Repair request escalated to a product event based on evaluation determined that device was overheating.

• Brand Name: ATT MR8 ANGLED STRAIGHT
• Type of Device: MOTOR, DRILL, ELECTRIC
• 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: 14080871
• MDR Text Key: 289105577
• Report Number: 1625507-2022-00063
• Device Sequence Number: 1
• Product Code: HBC
• UDI-Device Identifier: 00763000063610
• UDI-Public: 00763000063610
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K183515
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/12/2022

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
• Device Operator: Health Professional
• Device Model Number: MR8-AS10-R
• Device Catalogue Number: MR8-AS10-R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2022
• Initial Date FDA Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2018
• 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