PDS Z317HRecalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10705031060494), received between Mar 19, 2018 and Aug 11, 2026 — classified as 1 injury, 34 malfunctions.

The most frequently reported specific device problem is “Break” (22 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 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50211808 ↗
• MalfunctionFeb 18, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE WAS DETACHED FROM THE SUTURE EASILY. THERE IS A SWAGE PART OF A NEEDLE ATTACHED TO THE SUTURE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. ALTHOUGH THE NEEDLE BREAKAGE OCCURRED, THE NEEDLE PIECES DID NOT FALL INTO THE SURGICAL FIELD EVEN ONCE. ALL NEEDLE PIECES WERE RETRIEVED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24377940 ↗
• MalfunctionDec 1, 2025Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT THE SUTURE CAME OFF IN THE NEEDLE AND BEFORE THAT SUTURE BROKE. THERE WERE NO PATIENT ADVERSE EVENT. PRODUCT IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23682439 ↗
• MalfunctionJun 19, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22289924 ↗
• MalfunctionDec 13, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY. THE DOCTOR STOPPED TO USE IT. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20924026 ↗
• MalfunctionAug 7, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON STATED THE SUTURE WAS DULL AND NEEDED A NEW SUTURE BECAUSE THE SUTURE TIP HAD BROKE OFF. THE SUTURE TIP DISCOVERED IN THE GRIPS OF THE NEEDLE DRIVER. THE SUTURE TIP EXAMINED BY SURGICAL TEAM AND WAS DETERMINED TO BE COMPLETE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19927345 ↗
• MalfunctionJun 13, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT A SLEEVE GASTRECTOMY ON (B)(6) 2024, AND SUTURE WAS USED. SUTURE IS PASSED TO REINFORCE THE SLEEVE, THE SUTURE BEGINS TO BE PERFORMED. WHEN THE SUTURE IS PULLED, THE NEEDLE IS DISASSEMBLED AND REMAINS IN THE PATIENT'S ABDOMINAL CAVITY. THEY HAD TO SEARCH FOR IT FOR APPROXIMATELY TWENTY MINUTES AND USE IMAGE INTENSIFIER FOR LOCALIZATION. FINALLY THE NEEDLE WAS FOUND AND REMOVED FROM THE PATIENT CAVITY, A NEW SUTURE WAS PASSED TO FINISH THE PROCEDURE. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19528598 ↗
• MalfunctionMay 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. AT THE TIME OF OPENING THE SUTURE, THE NEEDLE WAS DISASSEMBLED FROM THE THREAD. THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19385765 ↗
• MalfunctionMay 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. AT THE TIME OF OPENING THE SUTURE, THE NEEDLE WAS DISASSEMBLED FROM THE THREAD. THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19385759 ↗
• MalfunctionSep 27, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, A SECOND SUTURE BROKE WHILE IN USE DURING A CASE. IT BROKE IN HALF, BOTH PIECES RETRIEVED REMOVED FROM FIELD. CONTINUOUS X-RAY BEING PERFORMED DURING THE PROCEDURE. NO CONCERN FOR RETAINMENT. THE SUTURE WAS THE SECOND TO BREAK IN THE CASE. IT IS UNKNOWN IF THERE WERE ANY PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17825928 ↗
• MalfunctionSep 27, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, A SECOND SUTURE BROKE WHILE IN USE DURING A CASE. IT BROKE IN HALF, BOTH PIECES RETRIEVED REMOVED FROM FIELD. CONTINUOUS X-RAY BEING PERFORMED DURING THE PROCEDURE. NO CONCERN FOR RETAINMENT. THE SUTURE WAS THE SECOND TO BREAK IN THE CASE. IT IS UNKNOWN IF THERE WERE ANY PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17825925 ↗
• MalfunctionJun 1, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE IN 2023 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, LAPAROSCOPIC CHOLECYSTECTOMY. THE NEEDLE BROKE WHILE WORKING IN THE ABDOMINAL CAVITY. THE NEEDLE WAS REMOVED FROM THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17039393 ↗
• MalfunctionFeb 3, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. A SCRUB NURSE FOUND THAT THE SUTURE HAD BEEN DETACHED FROM THE NEEDLE BEFORE USE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16294525 ↗
• MalfunctionDec 20, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE IN 2022 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY THE ACCOUNT CONTACT THAT THEY PURCHASED 2-0 PDS*II W/ SH TAPER NEEDLE FROM MWI ANIMAL HEALTH. INSIDE THE BOX IS 2-0 PDS*II W/CP-1 NEEDLE. NO PATIENT INVOLVEMENT WAS REPORTED. DEVICE WILL BE RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16014651 ↗
• MalfunctionNov 29, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12886614 ↗
• MalfunctionNov 29, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12886610 ↗
• MalfunctionNov 15, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON UNKNOWN DATE AND THE SUTURE WAS USED. THE PRODUCT WAS NOT USED ON THE PATIENT. UPON EVALUATION, A FRACTURE WAS OBSERVED AT THE SUTURE ATTACHMENT OF THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12816361 ↗
• InjuryMar 30, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE. IT WAS NECESSARY TO DO AN X-RAY AND TO EXTEND THE ANESTHESIA FOR 1 HOUR TO DETECT THE NEEDLE AND TO REMOVE IT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient; No Code Available; Not Applicable

  MAUDE report 9900748 ↗
• MalfunctionJan 6, 2020Defective Component; Defective Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. WHILE USING THE NEEDLE-SUTURE, IT WAS NOTICED THAT THE SUTURE BECAME THINNER FROM THE MIDDLE OF IT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9555198 ↗
• MalfunctionAug 13, 2019Material Frayed; Material Frayed

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS UNRAVELING. IT IS UNKNOWN HOW THE CASE WAS COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8890762 ↗
• MalfunctionAug 13, 2019Material Frayed; Material Frayed

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS UNRAVELING. IT IS UNKNOWN HOW THE CASE WAS COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8890761 ↗
• MalfunctionJun 6, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A METACARPAL PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. AT THE TIME OF KNOTTING AND STRETCHING THE SUTURE BROKE. IT DOES NOT HAVE THE ADEQUATE STRENGTH. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8674855 ↗
• MalfunctionApr 26, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE FELL OFF OF THE SUTURE DURING USE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8557765 ↗
• MalfunctionDec 12, 2018Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SNAPPED. THERE WERE NO ADVERSE CONSEQUENCES TO THE ANIMAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8156060 ↗
• MalfunctionDec 12, 2018Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SNAPPED. THERE WERE NO ADVERSE CONSEQUENCES TO THE ANIMAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8155791 ↗