MAUDE Adverse Event Report: MDT POWERED SURGICAL SOLUTIONS MOTOR LEGEND EHS STYLUS; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE

Model Number EM200

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

Repair request initiated for device with the report of detached collet.No patient impact reported.Repair request escalated to a product event based on reason for return.On follow-up no information provided on patient impact by health care professional.On further evaluation it was reported that the device was overheating.

Manufacturer Narrative

Report confirmed.The device was tested and the max temperature was measured to be 141°f.The likely cause was identified as worn front and rear bearings.It was also noted that motor sounds rough and shaft is cracked.The device user manual warnings section includes instructions that heavy side loads and/or long operating times may cause the device to overheat.If the device overheats, discontinue use and rest the device by using it intermittently, or wrap the device in a moist sterile towel.Use of an overheated device may cause injury to the patient or operator.We will continue to track and trend this complaint type.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MOTOR LEGEND EHS STYLUS
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE
• 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: 13124349
• MDR Text Key: 284524102
• Report Number: 1625507-2021-00394
• Device Sequence Number: 1
• Product Code: HBE
• UDI-Device Identifier: 00763000096649
• UDI-Public: 00763000096649
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K012456
• 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: 12/31/2021

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: EM200
• Device Catalogue Number: EM200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2021
• Initial Date FDA Received: 12/31/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2018
• 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