Arthrex® AR-2324BCCTT-1Recalls & reported problems
Arthrex, Inc. · BIO-COMP, SWIVELOCK C, TT, 4.75x19.1MM · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867283510), received between Feb 14, 2022 and Jun 21, 2023 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Break” (4 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.
Most reported problems
Device problems
- Break4
- Adverse Event Without Identified Device or Use Problem1
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 21, 2023Break; Break
IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE SCREW BROKEN WHILE TIGHTENING. ALL BROKEN PARTS WERE RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17171113 ↗MalfunctionDec 5, 2022Break; Mechanical Jam
IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE IMPLANT JAMMED IN THE BONE. NOTHING BROKE OFF. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. (B)(6) 2022 UPDATE. FURTHER INFORMATION WERE PROVIDED THAT THE CLIENT DECIDED THAT AFTER THE ANCHOR BECAME JAMMED, DUE TO A DAMAGED THREAD, TO HAMMER THE IMPLANT IN AND USE A NEW ONE TO FINISH THE SURGERY SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15913754 ↗MalfunctionApr 25, 2022Break
IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE A LOSS OF THE ENTIRE ANCHOR OCCURRED WHILE SCREWING. NO PART OF THE DEVICE BROKE OFF. THE DEVICE REMAINED INSIDE THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14193657 ↗MalfunctionApr 18, 2022Break
IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT KNEE ARTHROSCOPY THE PEEK PART OF THE DEVICE BROKE WHEN IT CAME IN CONTACT WITH THE BONE. ALL BROKEN PARTS WERE RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14136868 ↗InjuryFeb 14, 2022Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT HAS AN ALLERGY WITH AN INFLAMMATORY REACTION TO THE MATERIAL PLACED IN THE KNEE IN (B)(6) 2021. NO FURTHER INFORMATION WERE PROVIDED. 27-JAN-2022 UPDATE: FURTHER INFORMATION WERE PROVIDED THAT NO ADDITIONAL SURGERY WILL BE PERFORMED.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 13526036 ↗
Other Fastener, fixation, biodegradable, soft tissue devices
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- HEALICOIL 72205137Smith & Nephew, Inc. · Fastener, fixation, biodegradable, soft tissue427 reports
- HEALIX ADVANCE ORTHOCORD 222296Medos International Sàrl · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE320 reports
- TWINFIX 72202597Smith & Nephew, Inc. · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE288 reports
- Arthrex® AR-2324BCCArthrex, Inc. · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE254 reports
- HEALIX ADVANCE 222331Depuy Mitek, LLC · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE1 recall196 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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