PDS Z346HRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10705031060661), received between Nov 5, 2018 and Nov 3, 2025 — classified as 4 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Break” (12 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN ANIMAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THERE WERE 4 SUTURES, NEEDLE IS COMING OFF MATERIAL, COMING OF THE WEDGE DURING PROCEDURES. NO PATIENT CONSEQUENCE IS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23451848 ↗
• MalfunctionNov 3, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN ANIMAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THERE WERE 4 SUTURES, NEEDLE IS COMING OFF MATERIAL, COMING OF THE WEDGE DURING PROCEDURES. NO PATIENT CONSEQUENCE IS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23451665 ↗
• MalfunctionOct 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN ANIMAL PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED PER DISTRIBUTOR THAT 4 SUTURES, NEEDLE IS COMING OFF MATERIAL, COMING OF THE WEDGE DURING PROCEDURES. NO PATIENT CONSEQUENCE IS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23324118 ↗
• MalfunctionOct 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN ANIMAL PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED PER DISTRIBUTOR THAT 4 SUTURES, NEEDLE IS COMING OFF MATERIAL, COMING OF THE WEDGE DURING PROCEDURES. NO PATIENT CONSEQUENCE IS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23324110 ↗
• MalfunctionOct 17, 2025Material Separation; Insufficient Device Problem Information; Material Separation; Insufficient Device Problem Information

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN ANIMAL PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED PER DISTRIBUTOR THAT 4 SUTURES, NEEDLE IS COMING OFF MATERIAL, COMING OF THE WEDGE DURING PROCEDURES. NO PATIENT CONSEQUENCE IS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23324103 ↗
• MalfunctionOct 17, 2025Material Separation; Insufficient Device Problem Information; Material Separation; Insufficient Device Problem Information

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN ANIMAL PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED PER DISTRIBUTOR THAT 4 SUTURES, NEEDLE IS COMING OFF MATERIAL, COMING OF THE WEDGE DURING PROCEDURES. NO PATIENT CONSEQUENCE IS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23324091 ↗
• MalfunctionFeb 2, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EMERGENCY OPEN PERICARDIOTOMY ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN OPENING AND REMOVING THE SUTURE, IT IS EVIDENT THAT THE NEEDLE IMMEDIATELY BROKE. THE NEEDLE COULD NOT BE USED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18630900 ↗
• MalfunctionNov 6, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE THAT THE NEEDLE POPPED OFF WHILE SUTURING UNKNOWN TISSUE. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18079239 ↗
• MalfunctionSep 8, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ENT PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12440499 ↗
• MalfunctionSep 8, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ENT PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12440495 ↗
• MalfunctionJul 14, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN UTERINE SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN CLOSING THE ABDOMINAL FASCIA, THE SUTURE BROKE WHEN TENSION WAS APPLIED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12165545 ↗
• MalfunctionJan 13, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING SURGERY, WHEN TYING THE KNOT, THE PDS SUTURE BROKE TWICE. AS A RESULT, THERE WAS A SURGERY DELAY OF 15 MINUTES. A LIKE DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO FRAGMENTS GENERATED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11168446 ↗
• InjuryMar 9, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BREAST AUGMENTATION ON AN UNKNOWN DATE AND SUTURE WAS USED. FOLLOWING THE PROCEDURE, THE SUTURE DIDN¿T HOLD, CAUSING THE IMPLANT TO EXTRUDE. A DIFFERENT SUTURE WAS USED TO REPAIR THE SUTURE USED DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Code Available; Wound Dehiscence

  MAUDE report 9806335 ↗
• InjuryMar 9, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. ON AN UNKNOWN DATE POST OP, THE SUTURE DIDN'T HOLD, CAUSING THE IMPLANT TO EXTRUDE. A DIFFERENT SUTURE WAS USED TO REPAIR THE FAILED SUTURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Code Available; Wound Dehiscence

  MAUDE report 9805749 ↗
• InjuryMar 9, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. ON AN UNKNOWN DATE POST OP, THE SUTURE DIDN'T HOLD, CAUSING THE IMPLANT TO EXTRUDE. A DIFFERENT SUTURE WAS USED TO REPAIR THE FAILED SUTURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Code Available; Wound Dehiscence

  MAUDE report 9805711 ↗
• InjuryMar 9, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. ON AN UNKNOWN DATE POST OP, THE SUTURE DIDN'T HOLD, CAUSING THE IMPLANT TO EXTRUDE. A DIFFERENT SUTURE WAS USED TO REPAIR THE FAILED SUTURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Code Available; Wound Dehiscence

  MAUDE report 9805614 ↗
• MalfunctionJan 31, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LAPAROTOMY PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE IS BROKEN IN THE MIDDLE OF THE CLOSURE OF THE ABDOMINAL APONEUROSIS OF THE PATIENT IN A SUPRA UMBILICAL AND INFRAUMBILICAL LAPAROTOMY. THE PROCEDURE WAS DELAYED BY 60 MINUTES AND COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9655616 ↗
• MalfunctionJan 31, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LAPAROTOMY PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE IS BROKEN IN THE MIDDLE OF THE CLOSURE OF THE ABDOMINAL APONEUROSIS OF THE PATIENT IN A SUPRA UMBILICAL AND INFRAUMBILICAL LAPAROTOMY. THE PROCEDURE WAS DELAYED BY 60 MINUTES AND COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9655608 ↗
• MalfunctionMay 7, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY ON (B)(6) 2019 AND SUTURE WAS USED TO MAKE A FASCIA CLOSURE. DURING THE PROCEDURE, THE SURGEON PASSES POINT AND THE NEEDLE IS BROKEN IN HALF. THE PROCEDURE WAS PAUSED AND THE SURGEON LOOKED FOR THE FRAGMENT WITHOUT FINDING A REASON FOR WHICH WIDE INCISION, IS SOUGHT IN CAVITY AND ADIPOSE TISSUE BUT THE FRAGMENT IS NOT FOUND. THE SURGEON PALPATED THE FRAGMENT IN THE PLANE OF ADIPOSE TISSUE BUT IT WAS NOT POSSIBLE TO REMOVE IT FOR THIS REASON. THE SURGEON PROCEEDED TO CLOSURE OF THE CAVITY AND AN RX PLATE WILL BE MADE POSTOPERATIVELY. NO REINTERVENTION HAD TO BE MADE TO THE PATIENT. THE PATIENT IS IN GOOD CONDITION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 8587758 ↗
• MalfunctionMay 2, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. AT THE TIME OF MAKING THE KNOTS OF THE SUTURE, THE THREAD IS BROKEN TWICE. THE PROCEDURE WAS DELAYED FIFTEEN MINUTES. A NEW PRODUCT WAS OPENED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8576331 ↗
• MalfunctionMay 2, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OBGYN PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE OF THE SUTURE CLOSING THE ABDOMINAL WALL IS RELEASED FROM THE THREAD OF SUTURE. THE PROCEDURE WAS DELAYED BY FIFTEEN MINUTES. A NEW SUTURE WAS OPENED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8576260 ↗
• MalfunctionMay 2, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OBGYN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING CLOSING THE ABDOMINAL WALL THE SUTURE BREAKS SEVERAL TIMES. THE SURGERY WAS DELAYED BY 15 MINUTES. ANOTHER SUTURE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8575558 ↗
• MalfunctionApr 15, 2019Break; Break

  IT WAS REPORTED VIA MAUDE REPORT THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE BROKE DURING USE. IT WAS NOT REPORTED IF THE TIP WAS RETRIEVED. IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8515868 ↗
• MalfunctionNov 5, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2018 AND A SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS KNOTTED, AND THE PDS THREAD WAS BROKEN WHEN CLOSING THE ABDOMINAL WALL. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8037642 ↗