PDS Z339HRecalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 10705031060609), received between Sep 6, 2018 and May 1, 2026 — classified as 45 malfunctions.

The most frequently reported specific device problem is “Break” (40 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 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN HE USED IT, HE WAS BREAKING THE THREAD SEVERAL TIMES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25056965 ↗
• MalfunctionOct 30, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS THAT THE SUTURE WAS DETACHED EASILY EVEN THOUGH IT WAS NOT A CONTROL RELEASE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23424916 ↗
• MalfunctionMar 18, 2025Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SURGICAL PROCEDURE ON (B)(6)2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE MID SURGERY. THERE WERE NO CONSEQUENCES FOR THE ANIMAL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21634416 ↗
• MalfunctionMar 18, 2025Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE MID SURGERY. THERE WERE NO CONSEQUENCES FOR THE ANIMAL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21634397 ↗
• MalfunctionMar 18, 2025Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE MID SURGERY. THERE WERE NO CONSEQUENCES FOR THE ANIMAL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21634395 ↗
• MalfunctionMar 18, 2025Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE MID SURGERY. THERE WERE NO CONSEQUENCES FOR THE ANIMAL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21634394 ↗
• MalfunctionMar 18, 2025Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE MID SURGERY. THERE WERE NO CONSEQUENCES FOR THE ANIMAL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21634383 ↗
• MalfunctionMar 18, 2025Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE MID SURGERY. THERE WERE NO CONSEQUENCES FOR THE ANIMAL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21634380 ↗
• MalfunctionSep 19, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. WHEN THE SURGEON WAS TRYING TO TIE KNOT, THE SUTURE BROKE. ANOTHER DEVICE WAS USED TO EFFECTIVELY TO COMPLETE THE CASE WITHOUT ANY PATIENT HARM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20264063 ↗
• MalfunctionAug 28, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE. 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 20085346 ↗
• MalfunctionMar 14, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN UROLOGICAL PROCEDURE ON AN UNKNOWN DATE; AND A SUTURE WAS USED. DURING THE PROCEDURE THE SUTURE WAS DETACHED FROM THE NEEDLE IMMEDIATELY BECAUSE THE CONNECTION BETWEEN THE SWAGE PART WAS WEAK. 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 18906156 ↗
• MalfunctionJan 20, 2023Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE KEPT BREAKING WHEN BEING USED. IT WAS UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16217562 ↗
• MalfunctionJul 6, 2022Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 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 14940496 ↗
• MalfunctionJul 6, 2022Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 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 14940455 ↗
• MalfunctionMar 19, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN KNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE BREAKAGE OCCURRED 2 TIMES IN A ROW DURING USE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13827166 ↗
• MalfunctionMar 19, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN KNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE BREAKAGE OCCURRED 2 TIMES IN A ROW DURING USE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13827153 ↗
• MalfunctionNov 10, 2021Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN OVARIAN PEDICLES PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12788771 ↗
• MalfunctionNov 10, 2021Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN OVARIAN PEDICLES PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12788769 ↗
• MalfunctionNov 10, 2021Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN OVARIAN PEDICLES PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12788766 ↗
• MalfunctionNov 10, 2021Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN OVARIAN PEDICLES PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12788765 ↗
• MalfunctionSep 28, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE CAME OFF THE SUTURE AS SOON AS THE VET TOUCHED IT, DIDN'T EVEN GET IT OUT OF THE PACKAGING. ANOTHER LIKE DEVICE WAS USED. UPON EVALUATION OF THE RETURNED DEVICE, SHORT INSERTION WAS OBSERVED IN THE STRAND. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12543710 ↗
• MalfunctionAug 23, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN HIATAL HERNIA PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE THE SUTURE BROKE. IT IS UNKNOWN WHAT WAS BEING DONE AT THE TIME OF THE SUTURE BREAKAGE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12353879 ↗
• MalfunctionJul 13, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN VENTRAL HERNIA PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE STRANDS BROKE MIDWAY WHILE TYING A KNOT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12157788 ↗
• MalfunctionApr 28, 2021Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DISTRIBUTOR BY THE CUSTOMER THAT DURING AN UNKNOWN PROCEDURE THAT THE SUTURE CONSTANTLY BREAKING. IT IS UNKNOWN IF ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11738335 ↗
• MalfunctionApr 28, 2021Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DISTRIBUTOR BY THE CUSTOMER THAT DURING AN UNKNOWN PROCEDURE THAT THE SUTURE CONSTANTLY BREAKING. IT IS UNKNOWN IF ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11738326 ↗