HEWSON SUTURE RETRIEVER 71111579Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010510495), received between Sep 15, 2017 and May 5, 2021 — classified as 3 injuries, 2 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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 5, 2021Break; Break

  IT WAS REPORTED THAT DURING A DISTAL BICEP SURGERY, TWO HEWSON SUTURE RETRIEVER BROKE WHILE PASSED THROUGH THE DRILLED HOLE INSIDE THE PATIENT, RESULTING IN THE NEED FOR OPENING A THIRD HEWSON SUTURE RETRIEVER (PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE). A SURGICAL DELAY OF FEWER THAN 30 MINUTES WAS REPORTED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11777373 ↗
• InjuryMay 5, 2021Break; Break

  IT WAS REPORTED THAT DURING A DISTAL BICEP SURGERY, TWO HEWSON SUTURE RETRIEVER BROKE WHILE PASSED THROUGH THE DRILLED HOLE INSIDE THE PATIENT, RESULTING IN THE NEED FOR OPENING A THIRD HEWSON SUTURE RETRIEVER (PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE). A SURGICAL DELAY OF FEWER THAN 30 MINUTES WAS REPORTED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11777258 ↗
• MalfunctionDec 7, 2017Break; Break

  IT WAS REPORTED DURING A SURGERY TO REPAIR A FRACTURED PATELLA, THE SUTURE LOOP WAS WEAK AND BROKE. THERE WAS NO DELAY IN SURGERY AND NO PIECES LEFT IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7097449 ↗
• MalfunctionDec 7, 2017Break; Break

  IT WAS REPORTED DURING A SURGERY TO REPAIR A FRACTURED PATELLA THE SUTURE LOOP WAS WEAK AND BROKE. THERE WAS NO DELAY IN SURGERY AND NO PIECES LEFT IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7097447 ↗
• InjurySep 15, 2017Fracture; Fracture

  IT WAS REPORTED THAT DURING A PARTIAL PATELLECTOMY WITH PATELLAR TENDON ADVANCEMENT FOR PATELLA FRACTURE A SMITH & NEPHEW HEWSON SUTURE RETRIEVER WAS BEING USED WHEN A PIECE OF THE PASSER LOOP BROKE OFF AND WAS UNABLE TO BE RETRIEVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6869245 ↗