Arcus Staple System ARC-1310KRecalls & reported problems
Medartis Inc. · 13mm X 10mm Arcus Staple Kit · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00817701020196), received between Jan 15, 2020 and Jan 15, 2020 — classified as 1 malfunction.
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
- No Apparent Adverse Event1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 15, 2020No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT DURING A SURGERY WITH THE ARCUS STAPLE SYSTEM, THE DRILL WAS TIGHT IN THE DRILL GUIDE AND THE DRILL GUIDE BENT. DRILLING WAS ABLE TO BE COMPLETED. A STAPLE WAS PLACED AND THE SURGEON ATTEMPTED TO USE THE STAPLE INSERTER AS A TAMP. THE SURGEON COULD NOT RE-ENGAGE THE INSERTER WITH THE STAPLE. THIS OCCURED WITH TWO DIFFERENT STAPLES AND INSERTERS AND THE STAPLE COULD NOT BE FULLY SEATED AGAINST THE BONE. THE SURGEON REMOVED THE ARCUS STAPLE AND COMPLETED THE SURGERY WITH A MAX VPC SCREW. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9592632 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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