PDS PDP333HRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10705031048065), received between Aug 10, 2018 and Sep 17, 2026 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Break

  It was reported that a patient underwent a surgical procedure for a perforated ulcer on (b)(6) 2026 and suture was used. During the procedure, the suture snapped completely while closing the fascia. The fascia was then closed using a new suture of the same type. There was no adverse patient consequences reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50801776 ↗
• InjurySep 17, 2026Break

  It was reported that a patient underwent a surgical procedure for a perforated ulcer on (b)(6) 2026 and suture was used. The patient was reoperated on (b)(6) 2026 due to wound dehiscence. During the reoperation, it was discovered that the replacement suture had broken. Additional information was requested.

  Patient problems: Wound Dehiscence

  MAUDE report 50801775 ↗
• MalfunctionMay 14, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ANIMAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS UED. IT WAS REPORTED THAT CANINE PATIENT WENT HOME AFTER PROCEDURE AND A FEW DAYS LATER THE SUTURE FAILED AND THEY HAD TO GO TO THE ER FOR EMERGENCY SURGERY TO FIX THE ABDOMINAL WALL. THERE IS ADVERSE IMPACT PATIENT/USER. DEVICE IS NOT AVAILABLE FOR RETURN. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 25172026 ↗
• MalfunctionDec 3, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHILE SUTURING, THE NEEDLE AND SUTURE WAS DETACHED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23706653 ↗
• MalfunctionMay 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BREAKING WHEN THEY TIED THE KNOTS. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22061893 ↗
• MalfunctionMay 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BREAKING WHEN THEY TIED THE KNOTS. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22061874 ↗
• MalfunctionSep 10, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. PRIOR TO USE, THEY OPENED THE PACKET AND WHEN THEY PULLED THE NEEDLE OUT OF THE PACKET THE WHOLE NEEDLE CAME OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. UPON EVALUATION OF THE RETURNED DEVICE, SHORT INSERTION WAS OBSERVED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION REQUESTED AT TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20181897 ↗
• MalfunctionAug 5, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED THAT THE SUTURE HAD BEEN FOUND BROKEN BEFORE USING ON PATIENT DURING SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. DURING THE VISUAL INSPECTION OF THE RETURNED SAMPLE, NO ISSUES RELATED TO BREAKAGE SUTURES WERE FOUND ON THE STRAND. HOWEVER, SHORT INSERTION WAS OBSERVED IN THE STRAND. THE VISUAL INSPECTION CONCLUDED THAT THE COMBINATION OF THE NEEDLE/SUTURE WAS DETACHED FROM THE NEEDLE SINCE THE INSERTION END OF THE SUTURE DID NOT MEET THE REQUIREMENT. ADDITIONALLY, A PHOTO WAS PROVIDED AND IT SHOWED A FOIL AND SUTURE INSIDE A PLASTIC BAG. BASED ON THE INFORMATION CURRENTLY AVAILABLE, SHORT INSERTION ISSUE WAS IDENTIFIED AS PULL OUT DURING THE INVESTIGATION OF THE SAMPLE RECEIVED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19905791 ↗
• MalfunctionAug 24, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE JUST FELL OFF THE SUTURE MATERIAL WHEN OPENED FROM THE PACKAGING AND LOADED ONTO THE NEEDLE HOLDER. OPENED ANOTHER SUTURE TO CONTINUE WITH THE PROCEDURE. VISUAL INSPECTION WAS CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT ONE EMPTY LABELED WINDING FORMER, ONE DETACHED NEEDLE AND A SUTURE OF PRODUCT CODE PDP333H WERE RECEIVED FOR EVALUATION. AFTER INVESTIGATION OF THE SAMPLE SHORT INSERTION WAS OBSERVED IN THE STRAND, AND THE VISUAL INSPECTION CONCLUDED THAT THE COMBINATION OF THE NEEDLE/SUTURE WAS FOUND DETACHED SINCE THE INSERTION END OF THE SUTURE DID NOT MEET THE REQUIREMENT, THIS DEFECT IS CAUSED BECAUSE THE SUTURE WAS NOT CORRECTLY INSERTED INSIDE OF THE NEEDLE BARREL HOLE RESULTING IN A PULL-OUT DEFECT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15289590 ↗
• MalfunctionApr 5, 2021Break; Break

  PER USER FACILITY MEDWATCH FORM # 5099229. IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC BLADDER SLING PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE SURGERY, THE NEEDLE BROKE. THE SURGEON WAS NOT ABLE TO RETRIEVE THE PIECE THAT BROKE OFF. IT REMAINS IN PATIENT. IT IS UNKNOWN IF THE DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11613364 ↗
• InjuryDec 11, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT SHE UNDERWENT A STUMP RECONSTRUCTION PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SIGNS OF STAPH INFECTION WITHIN THREE DAYS AFTER DISCHARGE. ELEVEN DAYS POST PROCEDURE, AN ADDITIONAL PROCEDURE WAS PERFORMED WHERE THE WOUND WAS DRAINED, DEBRIDEMENT AND A DRAIN WAS PLACED WHICH WAS SECURED WITH "CLOTH LIKE" SUTURES WHICH CAUSED NO ISSUES. THE CAUSE OF THE STAPH INFECTION IS UNKNOWN. THE PATIENT EXPERIENCED SIX STITCH ABSCESSES, SUTURES NOT DISSOLVING AND POKING THROUGH OR ERUPTING THE INCISION. THE PATIENT EXPERIENCED MULTIPLE INFECTIONS AND WAS TREATED WITH MULTIPLE ANTIBIOTICS WITH NO RESOLUTION. THE PATIENT EXPERIENCED RASH. THE SUTURES WERE REMOVED ON (B)(6) 2018 AND THE INCISION WAS RE-CLOSED WITH STAPLES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Abscess; No Code Available; Not Applicable; Rash; Unspecified Infection

  MAUDE report 8153223 ↗
• MalfunctionAug 14, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE WHILE SUTURING INSIDE THE VAGINAL CANAL, THE SURGEON ENCOUNTERED SOMETHING HARD (REMAINS UNCLEAR WHETHER PERIOSTEUM OR A RETRACTOR). THE NEEDLE BROKE WHEN IT WAS FELT WHERE TYPICALLY THE NEEDLE WOULD BEND. THE SURGEON KEPT THE REMAINDER OF NEEDLE AND SUTURE MATERIAL. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7780484 ↗
• MalfunctionAug 10, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GALL BLADDER PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. THE SUTURE SNAPPED AWAY FROM THE NEEDLE WHEN CLOSING THE UMBILICUS. A DIFFERENT SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7773620 ↗
• MalfunctionAug 10, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GALL BLADDER PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. THE SUTURE SNAPPED AWAY FROM THE NEEDLE WHEN CLOSING THE UMBILICUS. A DIFFERENT SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7773585 ↗