MAUDE Adverse Event Report: ACUMED LLC ACU-SINCH KNTLS MINI SYS W/INSRTR 2.3; WASHER, BOLT NUT

Model Number	46-0040-S
Medical Device Problem Code	Implant subsidence (4078)
Health Effect - Clinical Code	Implant Pain (4561)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported: 78f presented with pain and thumb subsidence post-op.X-ray showed round button pull through.Patient is osteoporotic.Patient presented with pain prior to the 2 week mark.
Additional Manufacturer Narrative
No product has been received to date so an examination cannot be performed.No definitive conclusion can be made.No revision surgery has occurred or has been scheduled at the time of this report.If any updated information is received a follow up report will be submitted.

• Brand Name: ACU-SINCH KNTLS MINI SYS W/INSRTR 2.3
• Common Device Name: WASHER, BOLT NUT
• 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: aram tran ; 3885 arapaho rd; addison, TX 75001
• MDR Report Key: 25178711
• Report Number: 3025141-2026-00244
• Device Sequence Number: 10333527
• Product Code: HTN
• UDI-Device Identifier: 10806378124235
• UDI-Public: 10806378124235
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/14/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 46-0040-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Age: 78 YR
• Patient Sex: Female