NA 214528Recalls & reported problems
Depuy Mitek, LLC · Arthroscopic Suture Cutter · Class 1
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 10886705003747), received between Jan 27, 2021 and Jan 27, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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 16, 2026.
Most reported problems
Device problems
- Device-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 27, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE SHAFT AND HANDLE ON THE ARTHRO SUTURE CUTTER *EA DEVICE HAD A MOUNTING FAILURE. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. THERE NO ADVERSE PATIENT CONSEQUENCE S. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11238165 ↗
Other CUTTER, SURGICAL devices
- NA 214646Medos International Sàrl · CUTTER, SURGICAL361 reports
- Sklar Instruments 96-2666ASklar Corporation · CUTTER, SURGICAL1 recall0 reports
- Sklar Instruments 96-2666Sklar Corporation · CUTTER, SURGICAL1 recall0 reports
- Sklar Instruments 96-2667Sklar Corporation · CUTTER, SURGICAL1 recall0 reports
- Sklar Instruments 96-2671ASklar Corporation · CUTTER, SURGICAL1 recall0 reports
- NA 214605Medos International Sàrl · CUTTER, SURGICAL17 reports
- NA 388.750Synthes GmbH · CUTTER, SURGICAL14 reports
- Aortic Cutter 3.8MM AC-3038Maquet Cardiovascular LLC · Cutter, Surgical12 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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