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

Model Number EM200

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Chemical Exposure (2570)

Event Type  Injury  

Manufacturer Narrative

Report confirmed.Evaluation determined that error code 15 occurred on the ipc.The likely cause was identified as the motor stalling.Device history record # (b)(4) was reviewed and did not reflect any conditions related to the current, reported malfunction.The device user manual warnings section includes instructions to check the device for damage before use.If damage is found, the device should not be used.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 drill stopping and failing to power on within 2-3 seconds of startup and the console giving an error 15.The repair request was escalated to a product event due to product return in less than 90 days from purchase or repair.On follow up, it was confirmed that there was a 10-minute anesthesia extension because of the device malfunction where they need to repeatedly do testing to check for the cause of the issue.It was confirmed that there was no patient injury.

Manufacturer Narrative

Report confirmed.Evaluation determined that error code 15 occurred on the ipc.The likely cause was identified as the motor stalled.It was also noted that the cable was cut, housing was worn, device is sticking and failed the di electric test.Device history record #(b)(4) was reviewed and did not reflect any conditions related to the current, reported malfunction.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Upon further follow up, it was confirmed that there is no need for a second surgery and the procedure was completed the same day with no additional intervention.

• Brand Name: MOTOR LEGEND EHS STYLUS
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• 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 ; 9496801224
• MDR Report Key: 8749700
• MDR Text Key: 149684363
• Report Number: 1625507-2019-00055
• Device Sequence Number: 1
• Product Code: HBE
• UDI-Device Identifier: 00643169505537
• UDI-Public: 00643169505537
• Combination Product (y/n): N
• Reporter Country Code: EZ
• 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,Followup,Followup
• Report Date: 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 05/15/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2017
• 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
• Patient Outcome(s): Other