Arthrex® AR-1011Recalls & reported problems
Arthrex, Inc. · SPKD LGMNT STAPLE 11 MMX 20 MMLG · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867002548), received between Jun 19, 2024 and Nov 6, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 6, 2024Break; Break
ON 10/25/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA SEMS-06695106 THAT AN AR-1011 SPIKED LIGAMENT STAPLE BROKE. THIS OCCURRED DURING AN ANTERATERAL KNEE PROCEDURE ON (B)(6) 2024 WHEN THE DEVICE BROKE. THE FRAGMENT WAS REMOVED. THE CASE WAS COMPLETED WITH ANOTHER PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20622083 ↗InjuryJun 19, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN ACL BTB PROCEDURE, WHEN THE SURGEON IMPACTED THE AR-1011, IT TWISTED. A COUPLE OF ATTEMPTS WERE MADE TO REATTACH IT BUT IT WOULD NOT WORK. THE CASE WAS COMPLETED BY USING A NEW AR-1011.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19568889 ↗
Other STAPLE, FIXATION, BONE devices
- N/A StandardSynthes GmbH · Staple, Fixation, Bone2 recalls16 reports
- GII QUICKANCHOR ETHIBOND 212034Medos International Sàrl · STAPLE, FIXATION, BONE98 reports
- GII QUICKANCHOR ORTHOCORD 222983Medos International Sàrl · STAPLE, FIXATION, BONE94 reports
- Speed SE-0910Synthes GmbH · Staple, Fixation, Bone1 recall24 reports
- Speed Shift SE-2020-10Synthes GmbH · Staple, Fixation, Bone1 recall10 reports
- Lapiplasty SpeedPlate SK50Treace Medical Concepts, Inc. · Staple, Fixation, Bone59 reports
- Speed SE-1512Synthes GmbH · Staple, Fixation, Bone1 recall6 reports
- LUPINE ORTHOCORD 210709Depuy Mitek, LLC · STAPLE, FIXATION, BONE56 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 18, 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