MAUDE Adverse Event Report: ACUMED LLC 2.3MM QUICK RELEASE DRILL; BIT, DRILL

Model Number	80-0627
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported in a case in (b)(6) today when allegedly a drill snapped on one of their new sets (it's a set that they're trialing so it was reportedly a loan one was used).The drill is reportedly a 2.3mm quick release drill (code 80-0627).There was allegedly not any delay caused by this due to having a second drill on the set, so no effect on op (operation) times and won't have an effect on patient outcome.
Additional Manufacturer Narrative
To date, the device has not returned for evaluation, the root cause could not be established.Additional reporting on this event will be provided as a follow up report if more information becomes available.

• Brand Name: 2.3MM QUICK RELEASE DRILL
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer (Section G): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer Contact: kimberly banning ; 5885 ne cornelius pass road; hillsboro, OR 97124
• MDR Report Key: 22914489
• Report Number: 3025141-2025-00442
• Device Sequence Number: 15731030
• Product Code: HTW
• UDI-Device Identifier: 10806378043574
• UDI-Public: 10806378043574
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/28/2025

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 Model Number: 80-0627
• Device Catalogue Number: 80-0627
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown