Arthrex® AR-2323KBCCRecalls & reported problems
Arthrex, Inc. · 5.5MM BC KNOTLESS SWIVELOCK · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867351356), received between Sep 1, 2021 and May 13, 2024 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Break” (3 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
- Detachment of Device or Device Component2
- Failure to Advance1
Patient problems
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions3
- Failure of Implant1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 13, 2024Failure to Advance; Failure to Advance
ON 5/12/2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-2323KBCC BIOCOMPOSITE KNOTLESS SWIVELOCK WAS SPINNING AND WOULD NOT ADVANCE, THE SCREW WAS STUCK ON THE INSERTER SHAFT AND DID NOT SEAT ON THE BONE. SURGEON USED A NEW PRODUCT AND CASE WAS COMPLETED WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED ON 5/13/2022: THIS WAS DISCOVERED DURING AN RCR PROCEUDRE AND IT HAS BEEN CONFIRM THAT THE SCREW DID NOT BREAK INSIDE THE PATIENT, ONLY GOT STUCK TO THE INSERTER. CASE WAS COMPLETED USING ANOTHER AR-2323KBCC BIOCOMPOSITE KNOTLESS SWIVELOCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19298415 ↗MalfunctionFeb 28, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ON 02/09/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN AR-2323BCC SUTURE ANCHORS PEEK TIP SEPARATED FROM THE ANCHOR. THIS OCCURRED DURING A ROTATOR CUFF CASE ON (B)(6) 2024 DURING INSERTION OF THE ANCHOR. THE CASE WAS COMPLETED. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.
Patient problems: Insufficient Information
MAUDE report 18801155 ↗MalfunctionOct 6, 2023Break; Break
ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2323KBCC BIOCOMPOSITE KNOTLESS SWIVELOCK PEEK EYELET BROKE DURING INSERTION, AND THE ANCHOR COULD NOT BE IMPLANTED. ANOTHER ANCHOR WAS USED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A TRICEPS REPAIR PROCEDURE EON (B)(6) 2023. ADDITIONAL INFORMATION REQUESTED.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 17884704 ↗MalfunctionMay 1, 2023Break; Break
IT WAS REPORTED ON (B)(6) 2023 BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-2323KBCC KNOTLESS SWIVELLOCK EYELET BROKE AT THE JOINT OF THE METAL INSERTER WHEN SURGEON WAS TIGHTENING THE ANCHOR. CASE INVOLVEMENT, DEVICE BREAKS DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16843911 ↗MalfunctionSep 19, 2022Detachment of Device or Device Component
IT WAS REPORTED ON 08/01/2022 BY A ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-2323KBCC SUTURE ANCHOR TIP POPPED OFF. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15445972 ↗MalfunctionSep 1, 2021Break
IT WAS REPORTED THAT THE EYELET FOR THE AR-2323KBCC BROKE OFF INTO THE SHOULDER DURING A RCR CASE. THE EYELET WAS NOT RETRIEVED; AN AR-2323BCC WAS IMPLANTED ON TOP OF THE EYELET. PATIENT WAS (B)(6) YEAR OLD MALE.
Patient problems: Insufficient Information
MAUDE report 12405939 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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