PowerSuture 05.03.0181Recalls & reported problems
Riverpoint Medical, LLC · Suture · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810020084542), received between May 11, 2023 and May 11, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Component Misassembled” (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.
Most reported problems
Device problems
- Component Misassembled1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2023Component Misassembled; Component Misassembled
ACCORDING TO THE REPORTER, "DURING THE PRIMARY ARTHROSCOPY SURGERY, WHEN THE SCRUB TECH OPENED UP THE POWER SUTURE PASSING LOOP (MANUFACTURED BY RIVERPOINT MEDICAL), THERE WAS NO PASSING LOOP IN THE PACKAGE. IN THE PACKAGE, THERE WERE ONLY 2 STRIPPED SUTURES. A BACK-UP (SAME LOT) HAS BEEN USED AND THE SURGERY WAS COMPLETED SUCCESSFULLY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16913476 ↗
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.
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