MAUDE Adverse Event Report: ACUMED LLC ACUMED; BIT, DRILL

Model Number	80-0387
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Drill bit broke during surgery on elbow.

• Brand Name: ACUMED
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): ACUMED LLC; 5885 ne cornelius pass rd; cornelius OR 97124
• MDR Report Key: 16643401
• Report Number: 16643401
• Device Sequence Number: 14825509
• Product Code: HTW
• UDI-Device Identifier: 10806378041778
• UDI-Public: (01)10806378041778
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/09/2023
• Report Date (Section F): 03/09/2023

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: 80-0387
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/30/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Race: White
• Date Report Sent to FDA: 03/09/2023