Arthrex® AR-1322DSCRecalls & reported problems
Arthrex, Inc. · DISP INSTRS KIT FOR MINI S-TAK · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867010185), received between Jan 3, 2023 and Jan 3, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Device Damaged by Another Device” (1 report).
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.
Most reported problems
Device problems
- Device Damaged by Another Device1
- Difficult to Insert1
- Difficult to Remove1
- Physical Resistance/Sticking1
Patient problems
- Insufficient Information1
- Laceration(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 3, 2023Physical Resistance/Sticking; Difficult to Insert; Difficult to Remove; Device Damaged by Another Device; Physical Resistance/Sticking
ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-1322DSC DISPOSABLE INSTRUMENTS KITS 2.0MM DRILL, WHEN DRILLING INTO THE BONE THE DRILL COLD WELDED INTO THE GUIDE. THIS OCCURRED DURING A UCL REPAIR ON (B)(6) 2022, THEY ATTEMPTED TO REMOVE THE GUIDE FROM THE DRILL WITH A BLADE AND BITER. A SECOND SITE WAS DRILLED BUT THE ANCHOR PULLED OUT. THE 2.4 MINI BIOCOMPOSITE SUTURETAK WAS BEING USED. OPENED DISPOSABLE KIT, USED THE 2.0MM DRILL, WHEN DRILLING INTO THE BONE THE DRILL COLD WELDED INTO THE GUIDE. THEY ATTEMPTED TO REMOVE THE GUIDE FROM THE DRILL WITH A BLADE AND BITER. A SECOND SITE WAS DRILLED BUT THE ANCHOR PULLED OUT. THE SURGERY WAS COMPLETED BY USING THE TWO TUNNELS DRILLED AS A BONE BRIDGE TO TIE OVER.
Patient problems: Insufficient Information; Laceration(s)
MAUDE report 16086996 ↗
Other INSTRUMENT, MANUAL, SURGICAL, GENERAL USE devices
- Arthrex® AR-13995NArthrex, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE430 reports
- Arthrex® AR-12990NArthrex, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE197 reports
- Arthrex® AR-13991NArthrex, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE128 reports
- Arthrex® AR-8981-08SArthrex, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE1 recall3 reports
- Arthrex® AR-8981-06SArthrex, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE1 recall1 report
- Centurion EB16Centurion Medical Products Corporation · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE1 recall0 reports
- Medline Industries, Inc. DYNJ901391DMedline Industries, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE1 recall0 reports
- HarmonyAIR LAS0042Steris Corporation · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE1 recall0 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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