Arthrex® AR-8841RCRecalls & reported problems
Arthrex, Inc. · Reduction Clamp · 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 00888867441378), received between Jul 1, 2024 and Jun 4, 2025 — 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
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 4, 2025Material Twisted/Bent; Material Twisted/Bent
ON 05/01/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8841RC REDUCTION CLAMP PARTS THAT HOLD THE GUIDEWIRES ARE BENT OUT OF SHAPE, IMPEDING THE PASSING OF A GUIDEWIRE THROUGH THE CLAMP. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22143198 ↗MalfunctionFeb 21, 2025Break; Break
ON 02/07/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8841RC REDUCTION CLAMP WAS BROKEN. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21432469 ↗MalfunctionJul 1, 2024Break; Break
ON 6/4/2024 A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-8841RC REDUCTION CLAMP BROKE DURING A CASE, WITH NO AFFECT ON THE PATIENT OR THE OUTCOME OF THE CASE. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19643108 ↗
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