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	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the acusinch mini used according to technique guide, trigger pulled, flip button successfully deploy, pulled back on blue handle device, flip button fell through the drill hole opened second device to complete surgery - 12 minute delay.
Additional Manufacturer Narrative
One acu-sinch kntls mini sys w/insrtr was examined.The inserter with the suture and round button was returned, but not the flip button.The parts returned were visually examined but in order to determine the root cause, both the flip button and the 2.3mm drill associated with the system would have to be examined.No definitive conclusion can be made.

• 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: 23292238
• Report Number: 3025141-2025-00555
• Device Sequence Number: 17340078
• Product Code: LXH
• UDI-Device Identifier: 10806378124235
• UDI-Public: 10806378124235
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K243624
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• 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): 10/14/2025

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
• Device Lot Number: 661879
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown