MAUDE Adverse Event Report: ACUMED, LLC ACUTWIST® ACUTRAK® COMP. SCREW EXTRACTOR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	AI-EX20
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned for investigation.Additional reporting on this event will be provided as a follow up report at the conclusion of the investigation.Related report numbers (including this report) 3025141-2025-00494 3025141-2025-00553.
Event or Problem Description
It was reported that two extractors were broken.The broken fragments may remain inside the patient's body.The acutwist screw could not be removed and ultimately remained inside the body.
Additional Manufacturer Narrative
The returned extractors were visually inspected under magnification to confirm fracture.Under magnification, the batch numbers of the two acutwist® acutrak® comp.Screw extractors (pn ai-ex20) were confirmed.The fracture surfaces are jagged, with multiple fracture planes that all have a gritty and dull appearance, indicating brittle fractures from a single overload event.No other damage was observed on either of the extractors.Multiple scenarios are possible as to the failure of the extractor tip such as misalignment during insertion, encountering dense bone, hitting the acusinch implant.Therefore, no definitive conclusions can be made.Related report numbers (including this report) 3025141-2025-00494.

• Brand Name: ACUTWIST® ACUTRAK® COMP. SCREW EXTRACTOR
• 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: 23286576
• Report Number: 3025141-2025-00495
• Device Sequence Number: 5470567
• Product Code: LXH
• UDI-Device Identifier: 10806378054730
• UDI-Public: 10806378054730
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

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: AI-EX20
• Device Catalogue Number: AI-EX20
• Device Lot Number: 577312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2022
• 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: Unknown