ACUMED 46-0040-SRecalls & reported problems
Acumed LLC · Acu-Sinch Kntls Mini Sys w/Insrtr 2.3 · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10806378124235), received between Sep 19, 2025 and May 14, 2026 — classified as 1 injury, 5 malfunctions.
The most frequently reported specific device problem is “Off-Label Use” (4 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Off-Label Use4
- Implant subsidence1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Implant Pain1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryMay 14, 2026Implant subsidence
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.
Patient problems: Implant Pain
MAUDE report 25178711 ↗MalfunctionOct 15, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23292238 ↗MalfunctionSep 19, 2025Off-Label Use; Off-Label Use
IT WAS REPORTED THROUGH COMMUNICATIONS WITH ACUMED SALES REPRESENTATIVES AND DISTRIBUTORS THAT THE PRODUCT WAS USED IN AN OFF-LABEL CAPACITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23100997 ↗MalfunctionSep 19, 2025Off-Label Use; Off-Label Use
IT WAS REPORTED THROUGH COMMUNICATIONS WITH ACUMED SALES REPRESENTATIVES AND DISTRIBUTORS THAT THE PRODUCT WAS USED IN AN OFF-LABEL CAPACITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23100995 ↗MalfunctionSep 19, 2025Off-Label Use; Off-Label Use
IT WAS REPORTED THROUGH COMMUNICATIONS WITH ACUMED SALES REPRESENTATIVES AND DISTRIBUTORS THAT THE PRODUCT WAS USED IN AN OFF-LABEL CAPACITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23100994 ↗MalfunctionSep 19, 2025Off-Label Use; Off-Label Use
IT WAS REPORTED THROUGH COMMUNICATIONS WITH ACUMED SALES REPRESENTATIVES AND DISTRIBUTORS THAT THE PRODUCT WAS USED IN AN OFF-LABEL CAPACITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23100985 ↗
Other WASHER, BOLT NUT devices
- FIBULINK FGS-1000Synthes GmbH · Washer, Bolt Nut117 reports
- Arthrex® AR-2372BLOArthrex, Inc. · WASHER, BOLT NUT91 reports
- Arthrex® AR-8925SSArthrex, Inc. · WASHER, BOLT NUT79 reports
- Arthrex® AR-8925TArthrex, Inc. · WASHER, BOLT NUT71 reports
- Arthrex® AR-8926TArthrex, Inc. · WASHER, BOLT NUT61 reports
- RipCord STA001KTrimed, INC. · WASHER, BOLT NUT1 recall2 reports
- Arthrex® AR-7000-18TArthrex, Inc. · WASHER, BOLT NUT1 recall0 reports
- Arthrex® AR-8926SSArthrex, Inc. · WASHER, BOLT NUT35 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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