Arthrex® AR-1920NSFRecalls & reported problems
Arthrex, Inc. · SUTR ANCH,CRKSCRW · Class 2 · Implant
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 00888867022751), received between Jul 3, 2024 and Jan 22, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Use of Device Problem” (2 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
- Use of Device Problem2
- Break1
- Defective Device1
- Device Dislodged or Dislocated1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 22, 2026Use of Device Problem
ON 09-JAN-2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-1920NSF CORKSCREW HAD AN ANCHOR SYSTEM FAILURE, IT CAME LOOSE. THIS WAS DISCOVERED DURING USE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24147091 ↗MalfunctionAug 19, 2025Use of Device Problem; Defective Device; Use of Device Problem; Defective Device
ON 07/29/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-1920NSF SUTURE ANCHOR ROLLED UP AND SUTURES ALREADY CUT. THE CASE WAS COMPLETED USING ANOTHER 5.0 ANCHOR.
Patient problems: Insufficient Information
MAUDE report 22838146 ↗MalfunctionJul 3, 2024Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated
ON 06/6/2024 IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-1920NSF CORKSCREW PULLED OUT. THE CASE WAS COMPLETED USING ANOTHER AR-1920NSF CORKSCREW. THIS WAS DISCOVERED DURING A SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION WAS PROVIDED ON 06/11/2024, WHERE THE ARTHREX SUBSIDIARY EMPLOYEE STATED ANOTHER AR-1920NSF CORKSCREW WAS USED TO COMPLETE THE CASE. THE SUTURE DID BREAK AND THE FRAGMENTS WERE RETRIEVED. THE PATIENT HAD A REGULAR BONE QUALITY. THIS RESULTED IN A 10-MINUTE DELAY. THERE WAS NO ADDITIONAL ANESTHESIA ADMINISTERED AND THERE WASN'T ANY NEGATIVE EFFECT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19666452 ↗
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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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