MAUDE Adverse Event Report: ACUMED, LLC ACU-SINCH KNTLS MINI SYS W/INSRTR 2.3; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	46-0040-S
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported through communications with acumed sales representatives and distributors that the product was used in an off-label capacity.Per ifu , pkgi-014358-rev a, the intended use specifically for acu-sinch knotless mini (ask mini) is indicated for carpal metacarpal (cmc) join arthroplasty as an adjunct in the healing process of hematoma distraction arthroplasty by providing stabilization at the base of the first and second metacarpal when the trapezium has been excised due to osteoarthritis.In this reported incident, the surgeon used the ask mini for a lis franc repair.Acumed product managers and sales teams have communicated to the surgeon that this use is off-label and continued use in this manner, the surgeon agreed to assume all responsibility that meets the use not covered in the ifu.
Event or Problem Description
It was reported through communications with acumed sales representatives and distributors that the product was used in an off-label capacity.

• Brand Name: ACU-SINCH KNTLS MINI SYS W/INSRTR 2.3
• 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: 23100997
• Report Number: 3025141-2025-00455
• Device Sequence Number: 18314136
• Product Code: LXH
• UDI-Device Identifier: 10806378124235
• UDI-Public: 10806378124235
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K243624
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/19/2025

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
• Operator of Device: Health Professional
• Device Model Number: 46-0040-S
• Device Catalogue Number: 46-0040-S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 09/19/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown