PDS Z303HRecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10705031060357), received between Apr 18, 2019 and Aug 13, 2026 — classified as 1 injury, 26 malfunctions.

The most frequently reported specific device problem is “Break” (24 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50234743 ↗
• MalfunctionAug 12, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50227586 ↗
• MalfunctionAug 12, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50227585 ↗
• MalfunctionJun 21, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. NINE SUTURES BROKE OUT OF THE SAME LOT/BOX. SOME BROKE WHILE REMOVING IT FROM THE PACKAGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19584025 ↗
• MalfunctionJun 21, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. NINE SUTURES BROKE OUT OF THE SAME LOT/BOX. SOME BROKE WHILE REMOVING IT FROM THE PACKAGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19583996 ↗
• MalfunctionJun 21, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. NINE SUTURES BROKE OUT OF THE SAME LOT/BOX. SOME BROKE WHILE REMOVING IT FROM THE PACKAGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19583988 ↗
• MalfunctionJun 21, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. NINE SUTURES BROKE OUT OF THE SAME LOT/BOX. SOME BROKE WHILE REMOVING IT FROM THE PACKAGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19583898 ↗
• MalfunctionJun 21, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. NINE SUTURES BROKE OUT OF THE SAME LOT/BOX. SOME BROKE WHILE REMOVING IT FROM THE PACKAGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19583706 ↗
• MalfunctionJun 21, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. NINE SUTURES BROKE OUT OF THE SAME LOT/BOX. SOME BROKE WHILE REMOVING IT FROM THE PACKAGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19583694 ↗
• MalfunctionJun 21, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. NINE SUTURES BROKE OUT OF THE SAME LOT/BOX. SOME BROKE WHILE REMOVING IT FROM THE PACKAGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19583685 ↗
• MalfunctionJun 21, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. NINE SUTURES BROKE OUT OF THE SAME LOT/BOX. SOME BROKE WHILE REMOVING IT FROM THE PACKAGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19583679 ↗
• MalfunctionJun 21, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. NINE SUTURES BROKE OUT OF THE SAME LOT/BOX. SOME BROKE WHILE REMOVING IT FROM THE PACKAGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19583673 ↗
• MalfunctionMar 20, 2024Break; Break

  Z303H - 9 INDIVIDUAL SUTURES BROKE IN THE OR. 13 EA. UNUSED BEING RETURNED. WE NEED A TOTAL OF 22 CREDITS. THE SUTURE KEEPS BREAKING FOR NO KNOWN REASONS. CUSTOMER REFERENCE/PO/SERVICE (B)(4), WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, (B)(4). DEVICE PROPERTY OF? NONE, DEVICE IN POSSESSION OF? NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18944398 ↗
• MalfunctionMar 20, 2024Break; Break

  Z303H - 9 INDIVIDUAL SUTURES BROKE IN THE OR. 13 EA. UNUSED BEING RETURNED. WE NEED A TOTAL OF 22 CREDITS. THE SUTURE KEEPS BREAKING FOR NO KNOWN REASONS. CUSTOMER REFERENCE/PO/SERVICE --> Z303HDEFECTIVE, WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? --> NO, WAS PROCEDURE SUCCESSFULLY COMPLETED? --> YES, WERE FRAGMENTS GENERATED? --> UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? --> UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN, IP-01996209 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.--> TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18944386 ↗
• MalfunctionMar 20, 2024Break; Break

  Z303H - 9 INDIVIDUAL SUTURES BROKE IN THE OR. 13 EA. UNUSED BEING RETURNED. WE NEED A TOTAL OF 22 CREDITS. THE SUTURE KEEPS BREAKING FOR NO KNOWN REASONS. CUSTOMER REFERENCE/PO/SERVICE Z303HDEFECTIVE, WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, (B)(6). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18944379 ↗
• MalfunctionMar 20, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE DURING USE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18944378 ↗
• MalfunctionMar 20, 2024Break; Break

  Z303H - 9 INDIVIDUAL SUTURES BROKE IN THE OR. 13 EA. UNUSED BEING RETURNED. WE NEED A TOTAL OF 22 CREDITS. THE SUTURE KEEPS BREAKING FOR NO KNOWN REASONS. CUSTOMER REFERENCE/PO/SERVICE --> Z303HDEFECTIVE, WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? --> NO, WAS PROCEDURE SUCCESSFULLY COMPLETED? --> YES, WERE FRAGMENTS GENERATED? --> UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? --> UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN, IP-01996209 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.--> TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18944367 ↗
• MalfunctionMar 20, 2024Break; Break

  Z303H - 9 INDIVIDUAL SUTURES BROKE IN THE OR. 13 EA. UNUSED BEING RETURNED. WE NEED A TOTAL OF 22 CREDITS. THE SUTURE KEEPS BREAKING FOR NO KNOWN REASONS. CUSTOMER REFERENCE/PO/SERVICE. Z303H DEFECTIVE, WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY; UNKNOWN, IP-01996209 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18944366 ↗
• MalfunctionMar 20, 2024Break; Break

  Z303H - 9 INDIVIDUAL SUTURES BROKE IN THE OR. 13 EA. UNUSED BEING RETURNED. WE NEED A TOTAL OF 22 CREDITS. THE SUTURE KEEPS BREAKING FOR NO KNOWN REASONS. CUSTOMER REFERENCE/PO/SERVICE --> Z303HDEFECTIVE, WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? --> NO, WAS PROCEDURE SUCCESSFULLY COMPLETED? --> YES, WERE FRAGMENTS GENERATED? --> UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? --> UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN, IP-01996209 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.--> TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18944363 ↗
• MalfunctionMar 20, 2024Break; Break

  Z303H - 9 INDIVIDUAL SUTURES BROKE IN THE OR. 13 EA. UNUSED BEING RETURNED. WE NEED A TOTAL OF 22 CREDITS. THE SUTURE KEEPS BREAKING FOR NO KNOWN REASONS. CUSTOMER REFERENCE/PO/SERVICE Z303HDEFECTIVE, WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, (B)(6). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18944360 ↗
• MalfunctionMar 20, 2024Break; Break

  Z303H - 9 INDIVIDUAL SUTURES BROKE IN THE OR. 13 EA. UNUSED BEING RETURNED. WE NEED A TOTAL OF 22 CREDITS. THE SUTURE KEEPS BREAKING FOR NO KNOWN REASONS. CUSTOMER REFERENCE/PO/SERVICE Z303HDEFECTIVE, WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, (B)(6). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18944356 ↗
• MalfunctionFeb 5, 2024Break; Dull, Blunt; Break; Dull, Blunt

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PANCREATICODUODENECTOMY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING A THE PROCEDURE, THE NEEDLE COULD NOT BE PASSED THROUGH THE TISSUE SMOOTHLY FROM AROUND THE 5TH OR 6TH STITCH DURING PANCREATICOJEJUNOSTOMY WITH CONTINUOUS SUTURE. AROUND AT THE TIME OF THE END OF THE SUTURE, ALTHOUGH THE NEEDLE WAS NOT HELD, THE NEEDLE WAS BROKEN AT THE SWAGE PART. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18641187 ↗
• MalfunctionAug 22, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANAOTOMOSIS PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON WAS PERFORMING AN ANAOTOMOSIS WITH A SUTURE, HE WAS CLOSING THE KNOT THE SUTURE GOT BROKEN. THAN HE CHOOSED ANOTHER SUTURE OF THE SAME TYPE, BUT IT GOT BROKEN AS WELL. AT THE END HE HAD TO PERFORM THE ANATOMOSYS WITH ANOTHER KIND OF SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17600030 ↗
• MalfunctionAug 22, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANASTOMOSIS PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON WAS PERFORMING AN ANASTOMOSIS WITH A SUTURE, HE WAS CLOSING THE KNOT THE SUTURE GOT BROKEN. THAN HE CHOUSED ANOTHER SUTURE OF THE SAME TYPE, BUT IT GOT BROKEN AS WELL. AT THE END HE HAD TO PERFORM THE ANATOMOSES WITH ANOTHER KIND OF SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17600028 ↗
• MalfunctionApr 7, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE THREAD BROKE. NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11628893 ↗