Arsenal Ankle 340-60-005Recalls & reported problems
Trilliant Surgical, LLC · .062in x 3in Olive Wire, Arsenal Ankle · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00810028391727), received between Jul 21, 2025 and Feb 19, 2026 — classified as 1 injury, 7 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component7
- Mechanical Problem7
- Fracture1
Patient problems
- Foreign Body In Patient8
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryFeb 19, 2026Fracture
COMPLAINT - THE TIP OF THE THREADED OLIVE WIRE BROKE OFF AND WAS STCK INTO THE PATIENT. IT COULD NOT BE RETREVIED.
Patient problems: Foreign Body In Patient
MAUDE report 24397530 ↗MalfunctionOct 23, 2025Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component
COMPLAINT - THE THREADED OLIVES ARE BREAKING AND BROKEN FRAGMENTED PIECES LEFT IN PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 23367600 ↗MalfunctionSep 6, 2025Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component
COMPLAINT - IT WAS REPORTED THAT A PIECE OF WIRE WAS LEFT IN THE PATIENT, IT WAS PART OF A DISPOSABLE PRODUCT FROM ENOVIS THAT THE DOCTOR WAS USING FOR THE CASE.
Patient problems: Foreign Body In Patient
MAUDE report 22987259 ↗MalfunctionAug 11, 2025Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component
COMPLAINT - THE THREADED OLIVES ARE BREAKING AND BROKEN FRAGMENTED PIECES LEFT IN PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 22779292 ↗MalfunctionAug 11, 2025Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component
COMPLAINT - THE THREADED OLIVES ARE BREAKING AND BROKEN FRAGMENTED PIECES LEFT IN PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 22779291 ↗MalfunctionJul 21, 2025Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component
COMPLAINT - THE THREADED OLIVES ARE BREAKING AND BROKEN FRAGMENTED PIECES LEFT IN PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 22561979 ↗MalfunctionJul 21, 2025Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component
COMPLAINT - THE THREADED OLIVES ARE BREAKING AND BROKEN FRAGMENTED PIECES LEFT IN PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 22561977 ↗MalfunctionJul 21, 2025Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component
COMPLAINT - THE THREADED OLIVES ARE BREAKING AND BROKEN FRAGMENTED PIECES LEFT IN PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 22561976 ↗
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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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