PDS Z371TRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705031060821), received between May 3, 2019 and Oct 17, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR PER CUSTOMER THAT THEY HAVE ENCOUNTERED A SAFETY ISSUE IN THE OR WITH AN ETHICON SUTURE, THE SUTURE BROKE INSIDE THE PATIENT DURING USE, AND IT DID HAVE AN IMPACT ON THE PATIENT. THE BROKEN SUTURE WAS THROWN AWAY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23328071 ↗
• MalfunctionSep 18, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT TOTAL HIP REPLACEMENT AND AUTOGRAFT BONE GRAFTING TO THE LEFT ACETABULUM ON AN UNKNOWN DATE IN (B)(6) 2025 AND SUTURE WAS USED. WHILE THE SURGEON WAS SUTURING, THE POINTY PART OF THE SUTURE BROKE OFF. EVERYONE WAS AWARE. X-RAY WAS CALLED AND CONFIRMED THERE WAS NO RETAINED ITEM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23089557 ↗
• MalfunctionAug 20, 2025Break; Component Missing

  WHILE THE SURGEON WAS SUTURING - THE POINTY PART OF THE SUTURE (LOT: 106G3D - REF: Z371T ) BROKE OFF - EVERYONE WAS AWARE. X-RAY WAS CALLED AND CONFIRMED "NO RETAINED ITEM".

  Patient problems: Insufficient Information

  MAUDE report 22850178 ↗
• MalfunctionApr 18, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINAL PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE THREAD BROKE DURING THE SPINAL ARTHRODESIS PROCEDURE AT ITS FIRST FIXATION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21864669 ↗
• 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 12157791 ↗
• MalfunctionJul 12, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VENTRAL HERNIA REPAIR PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHILE TYING THE SCARTUS FACIA. 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 12151059 ↗
• MalfunctionMar 12, 2021Break; Material Discolored; Break; Material Discolored

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LOW ANTERIOR RESECTION 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 11477212 ↗
• MalfunctionJul 29, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON UNKNOWN DATE AND THE SUTURE WAS USED. IT WAS ALSO REPORTED THAT DURING THE SURGERY, IT WAS FOUND THAT THE NEEDLE HAD BEEN DETACHED FROM THE SUTURE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8838419 ↗
• MalfunctionJul 23, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND THE SUTURE WAS USED. DURING SUTURING OF THE FASCIA, A TIP OF THE NEEDLE BROKE OFF AND WAS NOT FOUND. AP AND LATERAL ABDOMINAL X-RAYS WERE NEGATIVE FOR NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8818382 ↗
• MalfunctionJul 8, 2019Break; Break

  IT WAS REPORTED VIA VOLUNTARY FACILITY MEDWATCH FORM THAT THE PATIENT UNDERWENT LAP-ASSISTED SIGMOID COLECTOMY ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE NEEDLE TIP BROKE OFF INTO THE NEEDLE HOLDER. BOTH PIECES OF THE DEVICE WERE RETRIEVED AND REMOVED FROM THE FIELD. TWO NEEDLES WERE OPENED AND IT IS UNSURE WHICH LOT NUMBER BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8767335 ↗
• MalfunctionJun 5, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HEMORRHOIDECTOMY PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. WHILE SUTURING, THE END OF THE NEEDLE BROKE OFF IN THE NEEDLE DRIVER. BOTH PIECES OF THE NEEDLE WERE REMOVED FROM THE STERILE FIELD. NO ADVERSE PATIENT OUTCOME REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8673080 ↗
• MalfunctionMay 3, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE. IT WAS UNKNOWN WHAT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8579248 ↗