Arthrex® AR-2324PSP-1Recalls & reported problems
Arthrex, Inc. · SwiveLock, SP PEEK 4.75MM · Class 2 · Implant
Data updated Oct 18, 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 00888867384583), received between Feb 26, 2025 and Aug 6, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break5
- Defective Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 6, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50160905 ↗MalfunctionJun 5, 2025Break; Break
IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY SURGERY, ALL 3 DEVICES BROKE OFF DURING IMPLANTATION. THE TIP OF THE DEVICE BENDED 90 DEGREES. THEREFORE, SELF-PUNCHING WAS NOT POSSIBLE. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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 22149999 ↗MalfunctionJun 5, 2025Break; Break
IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY SURGERY, ALL 3 DEVICES BROKE OFF DURING IMPLANTATION. THE TIP OF THE DEVICE BENDED 90 DEGREES. THEREFORE, SELF-PUNCHING WAS NOT POSSIBLE. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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 22149838 ↗MalfunctionJun 5, 2025Break; Break
IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY SURGERY, ALL 3 DEVICES BROKE OFF DURING IMPLANTATION. THE TIP OF THE DEVICE BENDED 90 DEGREES. THEREFORE, SELF-PUNCHING WAS NOT POSSIBLE. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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 22149757 ↗MalfunctionApr 3, 2025Defective Device; Defective Device
IT WAS REPORTED THAT THE DEVICE WAS FOUND TO BE DEFECTIVE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED.NO FURTHER INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21765987 ↗MalfunctionFeb 26, 2025Break; Break
IT WAS REPORTED THAT DURING A ROTATOR CUFF SPEED BRIDGE SURGERY THE ANCHOR BROKE OFF WHEN IT WAS INSERTED INTO THE BONE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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 14-FEB-2025: FURTHER INFORMATION WAS PROVIDED THAT THE BROKEN PIECES WERE RETRIEVED OUT OF THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21470969 ↗
Other Fastener, fixation, nondegradable, soft tissue devices
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- 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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