Arthrex® AR-7232-02Recalls & reported problems
Arthrex, Inc. · 2-0 FW LOOP 48" W/ØMOND NDL 26MM · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867041646), received between Mar 5, 2019 and Aug 17, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Insufficient Device Problem Information1
Patient problems
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 17, 2026Break
Patient problems: Insufficient Information
MAUDE report 50277186 ↗InjuryMar 5, 2019Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT UNDERWENT A LUNATE-SCAPHOID COMPLETE TEAR REPAIR PROCEDURE ON (B)(6) 2018 WHEN AN ARTHREX DEVICE WAS USED TO REPAIR A LIGAMENT TEAR IN HIS LEFT WRIST. HOLES WERE DRILLED INTO HIS WRIST BONES AND ONE IN THE RADIUS. ACCORDING TO THE PATIENT THE PROCEDURE FAILED AND HE NOW HAS TO UNDERGO ANOTHER SURGERY TO REMOVE THE DEVICES AND HIS WRIST BONES. PATIENT FURTHER STATES THAT A CT SCAN SHOWED DEGRADATION OF THE HOLES DRILLED FOR THE ARTHREX IMPLANT. THE SECOND SURGERY WILL TAKE PLACE ON (B)(6) 2019. THE PATIENT BELIEVES IT WOULD BE BENEFICIAL TO HAVE A REPRESENTATIVE PRESENT DURING SURGERY TO DETERMINE POST OP ON WHY THE INITIAL OPERATION HAD ISSUE. ADDITIONAL INFORMATION OBTAINED (B)(6) 2019: UPON REQUEST FOR ADDITIONAL INFORMATION THE PATIENT RESPONDED THAT HE WAS JUST GIVING ARTHREX A HEADS UP ABOUT HIS SITUATION BUT DOES NOT WANT TO GO THROUGH THE EFFORT TO OBTAIN/PROVIDE THE INFORMATION/DOCUMENTS THAT ARTHREX HAS REQUESTED. HE WILL ASK HIS CURRENT SURGEON TO PROVIDE HIS OPINION UPON REVISION TAKING PLACE AND WILL LET ARTHREX KNOW THE OUTCOME. NO PART NUMBERS HAVE BEEN PROVIDED TO DATE FROM THE ORIGINAL PROCEDURE. ADDITIONAL INFORMATION OBTAINED (B)(6
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8389952 ↗
Other SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE devices
- FAST-FIX 72202468Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 death6,626 reports
- FAST-FIX 72201491Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE863 reports
- FAST-FIX 72202469Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE561 reports
- FAST-FIX 72205676Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE439 reports
- Arthrex® AR-4501Arthrex, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE403 reports
- FAST-FIX 72205324Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE383 reports
- LUPINE ORTHOCORD 210712Medos International Sàrl · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE357 reports
- FAST-FIX 72201494Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE249 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.
How reports and recalls are matched · Editorial policy · Report an error on this page