Arthrex® AR-300SAGRecalls & reported problems
Arthrex, Inc. · SAW ATTACHMENT - SAGITTAL · Class 1
Data updated Oct 18, 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 00888867100251), received between May 24, 2024 and Sep 18, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Connection Problem” (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
- Connection Problem1
- Overheating of Device1
- Physical Resistance/Sticking1
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.
MalfunctionSep 18, 2026Overheating of Device
On (b)(6) 2026, a Cetas Healthcare notification was received via email indicating that information from a clinical study had been obtained. The report stated that the healthcare professional (HCP) reported HCP reported that overheating of attachment or connected components was observed during usage. HCP also reported that it was a use-related or handling issue and same adverse event was experienced previously. No additional treatment was required to treat the adverse event. Device causality was assessed by the HCP as probably related to the device.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50817093 ↗MalfunctionJan 5, 2026Physical Resistance/Sticking
IT WAS REPORTED THAT DURING THE SURGERY THE HEAD JAMMED AND THE BLADE WAS STUCK IN THE ATTACHMENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23960726 ↗MalfunctionMay 24, 2024Connection Problem; Connection Problem
IT WAS REPORTED THAT DURING THE SURGERY THE SAWBLADE CAME EASILY LOOSE IN THE DEVICE, BECAUSE THERE IS SOMETHING WRONG WITH THE BUTTON OF THE DEVICE. NO PART OF THE DEVICE BROKE OFF. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE, BUT THE ERROR WAS DESCRIBED AS INCONVENIENT. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19391465 ↗
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- NA 532.021Synthes GmbH · INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT521 reports
- NA 2570-04-501Depuy (Ireland) · INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT500 reports
- NA 532.110Synthes GmbH · INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT433 reports
- NA 05.001.223Synthes GmbH · INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT397 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.
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