PDS PDPB751DRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705031218871), received between Mar 4, 2020 and Jul 17, 2023 — classified as 3 malfunctions.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2023 AND BARBED SUTURE WAS USED. DURING SURGERY, THE NEEDLE TIP WAS BROKEN WHEN THE SURGEON WEAKLY HELD THE AREA NEAR THE NEEDLE TIP WITH A NEEDLE HOLDER. THE NEEDLE TIP WAS COLLECTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17332765 ↗
• MalfunctionJan 25, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY. IT WAS A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16244830 ↗
• MalfunctionMar 4, 2020Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING SURGERY, WHEN OPENING THE PACKAGE, IT WAS FOUND THAT THERE HAD BEEN A FOREIGN SUBSTANCE LIKE A HAIR. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9789831 ↗