ALPHAVENT 3911-856-547Recalls & reported problems
Stryker Corporation · ALPHAVENT KNOTLESS SP, 4.75MM, BIOCOMPOSITE ANCHOR · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327662030), received between Sep 9, 2025 and Sep 9, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (5 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
- Material Fragmentation5
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THAT SCREW PORTION BROKE WHEN SCREWING IN HARD BONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23011828 ↗MalfunctionSep 9, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THAT SCREW PORTION BROKE WHEN SCREWING IN HARD BONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23011827 ↗MalfunctionSep 9, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THAT SCREW PORTION BROKE WHEN SCREWING IN HARD BONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23011710 ↗MalfunctionSep 9, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT, SCREW PORTION BROKE WHEN SCREWING IN HARD BONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23011706 ↗MalfunctionSep 9, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THAT SCREW PORTION BROKE WHEN SCREWING IN HARD BONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23011705 ↗
Other Fastener, fixation, nondegradable, soft tissue devices
- TRUESPAN ORTHOCORD 228151Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,686 reports
- TRUESPAN ORTHOCORD 228152Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,398 reports
- OMNISPAN ORTHOCORD 228142Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE932 reports
- FOOTPRINT 72202901Smith & Nephew, Inc. · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE721 reports
- RIGIDLOOP 232447Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE633 reports
- Arthrex® AR-3636Arthrex, Inc. · Fastener, fixation, nondegradable, soft tissue624 reports
- OMNISPAN ORTHOCORD 228141Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE609 reports
- TRUESPAN ORTHOCORD 228162Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE460 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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