Arthrex® AR-2323PSLMRecalls & reported problems
Arthrex, Inc. · PEEK SWIVELOCK SP, 5.5x24.5MM · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867026803), received between Jul 11, 2022 and Apr 26, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
1 FDA recall record name this device's identifier.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Mar 24, 2017Terminated
Some eyelets broke from SwiveLock Anchor on insertion.
Z-2042-2017 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Break1
- Material Twisted/Bent1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 26, 2024Material Twisted/Bent; Material Twisted/Bent
THE SURGEON TRIED TO IMPLANT 2 X 5.5 SELF PUNCHING SWIVELOCKS IN THE MANNER HE WOULD NORMALLY USE THEM FOR A LATERAL ROW IN AN OPEN ROTATOR CUFF REPAIR AND THE TIPS BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19190882 ↗MalfunctionJul 11, 2022Break
IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY THE ANCHOR BROKE WHEN THE SURGEON WAS INSERTING IT INTO THE BONE. 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. UPDATE ON (B)(6) 2022 IT WAS CONFIRMED THAT ALL BROKEN PARTS WERE RETRIEVED FROM THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 14976059 ↗
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- HEALICOIL 72205137Smith & Nephew, Inc. · Fastener, fixation, biodegradable, soft tissue427 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.