PDS Z333HRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10705031060548), received between Apr 10, 2018 and Mar 11, 2026 — classified as 1 injury, 22 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLES WERE POPPING OFF, AND THIS HAPPENED MULTIPLE TIMES IN THE SAME BOX/LOT NUMBER. NO PATIENT CONSEQUENCES REPORTED. DEVICES ARE RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24570618 ↗
• MalfunctionMar 11, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLES WERE POPPING OFF, AND THIS HAPPENED MULTIPLE TIMES IN THE SAME BOX/LOT NUMBER. NO PATIENT CONSEQUENCES REPORTED. DEVICES ARE RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24570396 ↗
• MalfunctionOct 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, SALES REP IS REPORTING FROM THE CUSTOMER THAT THE SUTURES WERE POPPING OFF FROM THE NEEDLE DURING AN UNKNOWN CASE. THEY WERE ABLE TO RETRIEVE THE NEEDLE WITHOUT ANY PATIENT HARM. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20509969 ↗
• MalfunctionOct 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, SALES REP IS REPORTING FROM THE CUSTOMER THAT THE SUTURES WERE POPPING OFF FROM THE NEEDLE DURING AN UNKNOWN CASE. THEY WERE ABLE TO RETRIEVE THE NEEDLE WITHOUT ANY PATIENT HARM. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20509743 ↗
• MalfunctionOct 17, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP, THE SUTURE WAS POPPING OFF FROM THE NEEDLE. IT WAS POPPING OFF WHEN CLOSING THE ABDOMEN, THEY HAD TO OPEN A SECOND SUTURE AND THAT DID THE SAME THING. CASE WAS COMPLETED. NO PATIENT HARM. PRODUCT IS NOT AVAILABLE FOR RETURN. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20473525 ↗
• MalfunctionOct 17, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP, THE SUTURE WAS POPPING OFF FROM THE NEEDLE. IT WAS POPPING OFF WHEN CLOSING THE ABDOMEN, THEY HAD TO OPEN A SECOND SUTURE AND THAT DID THE SAME THING. CASE WAS COMPLETED. NO PATIENT HARM. PRODUCT IS NOT AVAILABLE FOR RETURN. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20473029 ↗
• InjuryAug 27, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE THREAD BROKE AND THE NEEDLE DISPERSED INTO THE CAVITY. IT WAS IDENTIFIED DURING CAVITY CLOSURE THAT THE THREAD BROKE AND THE NEEDLE DISPERSED INTO THE CAVITY. THE FACT WAS PROMPTLY IDENTIFIED BY THE SURGICAL TEAM, WHO BEGAN THE CAVITY INSPECTION TO FIND THE MATERIAL. HOWEVER, ACCORDING TO THE SURGEON'S REPORT, THERE WAS DIFFICULTY VIEWING BY LAPAROSCOPY, THEY CHANGED THE OPTICS AND VIDEO, BUT WITHOUT SUCCESS. IT WAS THEN CHOSEN TO REFER THE PATIENT TO CT SCAN FOR IDENTIFICATION OF THE MATERIAL IN THE ABDOMINAL CAVITY. THE NEEDLE WAS IDENTIFIED IN THE LEFT HYPOCHONDRIUM AND REMOVED BY A NEW LAPAROSCOPY. THE PATIENT WAS REFERRED TO THE PACU WITHOUT COMPLAINTS AND HEMODYNAMICALLY STABLE, HE WAS ORIENTED BY THE TEAM ABOUT ALL THE PROCESS THAT OCCURRED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20074661 ↗
• MalfunctionMar 13, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024, AND SUTURE WAS USED. THE NEEDLE BROKE OFF THE SUTURE WHEN HANDING IT OFF THE SCRUB NURSE. THE SUTURE WAS LOST FOR 30 MINUTES. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18895597 ↗
• MalfunctionAug 29, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. POST-OP, IT WAS REPORTED BY THE ACCOUNT CONTACT THAT A PATIENT PRESENTED WITH A REACTION TO THE SUTURE USED DURING THEIR PROCEDURE. STARTED LOOKING LIKE A BRUISE WHERE A KNOT OF THE SUTURE WAS LOCATED THEN THE VERY TOP LAYER OF TISSUE IS OPENING UP AND IS PROGRESSIVELY MOVING DOWN THE SUTURE LINE FROM STITCH TO STITCH (INTERRUPTED SUTURE LINE). INITIAL SPOT IS HEALING WELL. PATIENT WAS SENT HOME WITH CLAVAMOX. UPON RETURNING TODAY IS CAN BE SEEN THAT EACH STITCH IS OPENING UP AND THE SUTURE IS BEING REMOVED. PLANNING TO MEDICALLY TREAT/MANAGE AS NEEDED.. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Ecchymosis; Skin Inflammation/ Irritation; Wound Dehiscence

  MAUDE report 17644959 ↗
• MalfunctionJun 19, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR THAT THE CUSTOMER REPORTED THREE PACKAGES HAVE HAD NEEDLE COME DETACHED FROM SUTURE.¿ IT IS UNKNOWN WHEN THE EVENT OCCURRED. THE DEVICE IS NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17159862 ↗
• MalfunctionJun 19, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR THAT THE CUSTOMER REPORTED THREE PACKAGES HAVE HAD NEEDLE COME DETACHED FROM SUTURE.¿ IT IS UNKNOWN WHEN THE EVENT OCCURRED. THE DEVICE IS NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17159860 ↗
• MalfunctionJun 19, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON (B)(6)2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR THAT THE CUSTOMER REPORTED THREE PACKAGES HAVE HAD NEEDLE COME DETACHED FROM SUTURE.¿ IT IS UNKNOWN WHEN THE EVENT OCCURRED. THE DEVICE IS NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17159859 ↗
• MalfunctionNov 7, 2022Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE LINES KEPT BREAKING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15743879 ↗
• MalfunctionNov 7, 2022Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE LINES KEPT BREAKING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15743853 ↗
• MalfunctionJun 3, 2022Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14598392 ↗
• MalfunctionMar 24, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A COLPOPEXY PROCEDURE (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON WOULD USE THE SUTURE TO TIE A KNOT. AS THE SURGEON TIGHTENS DOWN THE SURGICAL KNOT, THE SUTURE BROKE. THIS HAPPENED FOUR TIMES. THE SURGEON HAD TO USE A DIFFERENT SIZE SUTURE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13894031 ↗
• MalfunctionMar 24, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A COLPOPEXY PROCEDURE (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON WOULD USE THE SUTURE TO TIE A KNOT. AS THE SURGEON TIGHTENS DOWN THE SURGICAL KNOT, THE SUTURE BROKE. THIS HAPPENED FOUR TIMES. THE SURGEON HAD TO USE A DIFFERENT SIZE SUTURE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13893901 ↗
• MalfunctionMar 24, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A COLPOPEXY PROCEDURE (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON WOULD USE THE SUTURE TO TIE A KNOT. AS THE SURGEON TIGHTENS DOWN THE SURGICAL KNOT, THE SUTURE BROKE. THIS HAPPENED FOUR TIMES. THE SURGEON HAD TO USE A DIFFERENT SIZE SUTURE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13893890 ↗
• MalfunctionMar 24, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A COLPOPEXY PROCEDURE (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON WOULD USE THE SUTURE TO TIE A KNOT. AS THE SURGEON TIGHTENS DOWN THE SURGICAL KNOT, THE SUTURE BROKE. THIS HAPPENED FOUR TIMES. THE SURGEON HAD TO USE A DIFFERENT SIZE SUTURE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13893801 ↗
• MalfunctionApr 14, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC PROCEDURE ON (B)(6) 2020; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE TAPER NEEDLE TIP BROKE OFF WHILE CLOSING ABDOMINAL FASCIA. THE PATIENT HAD TO HAVE A SLIGHT INCREASE IN INCISION AND AN X-RAY TO FIND THE TIP AND RETRIEVE IT. PATIENT HAS BEEN RELEASED WITHOUT COMPLICATION. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9959692 ↗
• MalfunctionOct 23, 2019Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE SURGERY, THE SUTURE LINE KEPT BREAKING ON SEVERAL INDIVIDUAL PACKS. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9226964 ↗
• MalfunctionJun 26, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE IN THE MIDDLE OF THE STRAND DURING EXTRACORPORAL KNOT TYING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7638307 ↗
• MalfunctionApr 10, 2018Break; Break

  IT WAS REPORTED SUTURE WAS USED DURING A VETERINARIAN PROCEDURE. THE NEEDLE BROKE APPROXIMATELY 2 MM ABOVE THE SWAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7413157 ↗