MAUDE Adverse Event Report: ACUMED, LLC 1.5MM EASYOUT, QR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	80-0598
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The root cause has been established through acumed's health hazard evaluation process.Acumed is taking appropriate actions to address this root cause.Additional reporting on this event will be provided as a follow up report if alternative information becomes available.Related reports (including this report): 3025141-2026-00070, 3025141-2026-00071, 3025141-2026-00101, 3025141-2026-00102.
Event or Problem Description
It was reported that during a removal surgery, two 1.5 hex drivers were used to remove the 2.3 screws from the plate and broke in the process.The 1.5 easy out was also used to remove the same screws and was damaged in the process as well.A screw removal set, schula and metal cutters were used to complete this procedure.There was a reported delay of 30-40 minutes.

• Brand Name: 1.5MM EASYOUT, QR
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 24100237
• Report Number: 3025141-2026-00072
• Device Sequence Number: 10469443
• Product Code: LXH
• UDI-Device Identifier: 10806378043291
• UDI-Public: 10806378043291
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K233311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 80-0598
• Device Catalogue Number: 80-0598
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male