Arthrex® AR-12160Recalls & reported problems
Arthrex, Inc. · SCISSORS, 3.4 MM, L CURVED, STR · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867005266), received between Jan 23, 2023 and Jun 7, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (2 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
- Break2
- Corroded1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 7, 2024Corroded; Corroded
ADDITIONAL INFORMATION WAS PROVIDED ON 05/16/2024 WHERE IT WAS STATED THAT THIS EVENT OCCURRED DURING A SHOULDER SURGERY THAT WAS COMPLETED USING ANOTHER CLAMP.
Patient problems: Insufficient Information
MAUDE report 19492911 ↗MalfunctionOct 31, 2023Break; Break
ON 10/2/2023, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS-06046857 THAT AN AR-12160 SCISSORS CALIPER IS BROKEN. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2023, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION RECEIVED ON 10/3/2024: AR-12160 SCISSORS BROKE AT THE TIP. THE DEVICE DID NOT BREAK INSIDE THE PATIENT. THE CASE WAS COMPLETED USING ANOTHER CLAMP. THIS WAS DISCOVERED DURING A SHOULDER SCOPE PROCEDURE ON (B)(6) 2023, WITH NO REPORTED ADVERSE EVENT OR PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18039292 ↗MalfunctionJan 23, 2023Break
ON (B)(6) 2023 IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-12160 CURVED SCISSORS BROKE DURING SURGERY. THE FRONT OF THE DISTAL TIP BROKE BUT WAS RETRIEVED FROM THE PATIENT. NO ADVERSE PATIENT AFFECT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 16223377 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
- AML EXCEL 2001-42-000Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2,009 reports
- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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.
How reports and recalls are matched · Editorial policy · Report an error on this page