MAUDE Adverse Event Report: MEDTRONIC XOMED INC. IPC HANDPIECE - STYLUS TOUCH; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number	EM210
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A healthcare professional (hcp) reported via a manufacturer representative that the handpiece was broken.On follow-up, it was reported that the handpiece was running hot almost immediately when the surgeon started using the drill.It was determined by the scrub tech and she confirmed with the surgeon that the attachment wasn¿t locked on the drill properly, therefore causing it to run hot.They brought in another drill and continued the case.So there was maybe a 5 minute delay.The surgeon has been in serviced on how to not unlock the drill while using the drill during surgery to prevent this from happening again.The drill has been put back in service because it was determined that it was user error and the drill will not be sent back to the manufacturer.There is no problem with the drill.It has been used again and no over heating problem occurred.It was noted that this surgeon is a new surgeon at the hospital and was not a drill user at his previous hospital.He is now very aware that the attachment has to be turned twice to lock the attachment in the drill to prevent this from happening in the future.There was no patient impact or injury.

• Brand Name: IPC HANDPIECE - STYLUS TOUCH
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 10829538
• Report Number: 1045254-2020-00549
• Device Sequence Number: 2959772
• Product Code: HBE
• UDI-Device Identifier: 00643169945388
• UDI-Public: 00643169945388
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K081475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/12/2020

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
• Operator of Device: Health Professional
• Device Model Number: EM210
• Device Catalogue Number: EM210
• Device Lot Number: 220654706
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 11/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1