MONOCRYL MCP496GRecalls & reported problems

Summary

The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 10705031046597), received between Jan 3, 2019 and Feb 27, 2026 — classified as 3 injuries, 84 malfunctions.

The most frequently reported specific device problem is “Break” (68 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 25 most recent of 87 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2026Break

  IT WAS REPORTED TO THE DL BY THE SALES REP THAT THE NEEDLE BROKE OFF OF THE TIP. 2/3 FROM THE TIP THE NEEDLE BROKE OFF WHILE SUTURING THE SKIN. THIS HAS HAPPENED BEFORE WITH THE SAME SURGEON. THIS HAPPENED ON (B)(6) AND THEY HAVE 9 SUTURES TO RETURN. THERE IS NO ADVERSE IMPACT PATIENT/USER REPORTED. DEVICES ARE AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24471978 ↗
• MalfunctionFeb 27, 2026Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2026 AND A SUTURE WAS USED. THE NEEDLE BROKE OFF OF THE TIP WHILE SUTURING THE SKIN. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24471974 ↗
• MalfunctionJan 30, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6)2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT DURING AN UNKNOWN PROCEDURE THAT THE TIP OF THE NEEDLE BROKE OFF. A MAGNET WAS USED TO SEARCH THE ROOM AND AN X-RAY WAS USED TO SEARCH THE PATIENT. THE TIP OF THE NEEDLE WAS NOT FOUND IN THE ROOM OR IN THE PATIENT. IT WAS CONFIRMED BY THE RADIOLOGY THAT THE TIP OF THE NEEDLE WAS NOT RETAINED. THERE WAS A SIGNIFICANT DELAY SEARCHING FOR THE TIP OF THE NEEDLE BUT AN EXACT AMOUNT OF TIME WAS NOT GIVEN.. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24225674 ↗
• MalfunctionDec 30, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THYROIDECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23921887 ↗
• MalfunctionDec 12, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING LAPAROSCOPIC HERNIA PORT SITE CLOSURE PROCEDURE, THE SUTURE FRAYED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS UNKNOWN FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23788801 ↗
• MalfunctionNov 20, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING C-SECTION PROCEDURE, THE TIP OF NEEDLE BROKE OFF DURING THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23609640 ↗
• InjuryAug 26, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOT ASSISTED LAPAROSCOPIC HYSTERECTOMY ON (B)(6) 2025 AND SUTURE WAS USED. THE PROCEDURE WENT WELL AND THE PATIENT TOLERATED EVERYTHING APPROPRIATELY. THE NEXT DAY ON (B)(6) 2025, THE ON CALL OB GOT CALLED TO THE BEDSIDE FOR THIS PATIENT DUE TO THE SUTURE OPENING ON ALL THREE INCISION SITES, LEAVING PARTICLES EVERY WHERE. THE SITE WAS CLEANED AND CLOSED AGAIN WITH A SUTURE AND A TOPICAL SKIN ADHESIVE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22895888 ↗
• InjuryAug 26, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOT ASSISTED LAPAROSCOPIC HYSTERECTOMY ON (B)(6) 2025 AND SUTURE WAS USED. THE PROCEDURE WENT WELL AND THE PATIENT TOLERATED EVERYTHING APPROPRIATELY. THE NEXT DAY ON (B)(6) 2025, THE ON CALL OB GOT CALLED TO THE BEDSIDE FOR THIS PATIENT DUE TO THE SUTURE OPENING ON ALL THREE INCISION SITES, LEAVING PARTICLES EVERY WHERE. THE SITE WAS CLEANED AND CLOSED AGAIN WITH A SUTURE AND A TOPICAL SKIN ADHESIVE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22895841 ↗
• InjuryAug 26, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOT ASSISTED LAPAROSCOPIC HYSTERECTOMY ON (B)(6) 2025 AND SUTURE WAS USED. THE PROCEDURE WENT WELL AND THE PATIENT TOLERATED EVERYTHING APPROPRIATELY. THE NEXT DAY ON (B)(6) 2025, THE ON CALL OB GOT CALLED TO THE BEDSIDE FOR THIS PATIENT DUE TO THE SUTURE OPENING ON ALL THREE INCISION SITES, LEAVING PARTICLES EVERY WHERE. THE SITE WAS CLEANED AND CLOSED AGAIN WITH A SUTURE AND A TOPICAL SKIN ADHESIVE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22895829 ↗
• MalfunctionJun 27, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE SURGEON HAD USED TWO OF THE SUTURES AND THE NEEDLE POPPED OFF FROM THE DEVICE TWICE. NO ADVERSE IMPACT PATIENT/USER. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22347651 ↗
• MalfunctionJun 27, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE SURGEON HAD USED TWO OF THE SUTURES AND THE NEEDLE POPPED OFF FROM THE DEVICE TWICE. NO ADVERSE IMPACT PATIENT/USER. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22347646 ↗
• MalfunctionJun 5, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A HYSTERECTOMY PROCEDURE THAT THE TIP OF THE NEEDLE BROKE DURING SKIN CLOSURE. NEEDLE FRAGMENT WAS RECOVERED. UNKNOWN IF X-RAY WAS NEEDED. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO DEVICE RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22150985 ↗
• MalfunctionApr 22, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE TIP OF THE SUTURE BROKE AFTER USING TO A PATIENT DURING AN OPERATION. CONSULTANT NOT CONCERN OF ANY HARM TO THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21884599 ↗
• MalfunctionApr 17, 2025Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21860604 ↗
• MalfunctionApr 17, 2025Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21859138 ↗
• MalfunctionMar 20, 2025

  SEVERAL SUTURE FROM THE SAME LOT BROKE WHILE USING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21651721 ↗
• MalfunctionDec 10, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE WAS SECURED INTO TISSUE. ONCE THEY WENT TO TIE THE KNOT. THE SUTURE WOULD BREAK. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20891235 ↗
• MalfunctionDec 10, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE WAS SECURED INTO TISSUE. ONCE THEY WENT TO TIE THE KNOT. THE SUTURE WOULD BREAK. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20891229 ↗
• MalfunctionDec 10, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE WAS SECURED INTO TISSUE. ONCE THEY WENT TO TIE THE KNOT. THE SUTURE WOULD BREAK. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20891223 ↗
• MalfunctionDec 10, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE WAS SECURED INTO TISSUE. ONCE THEY WENT TO TIE THE KNOT. THE SUTURE WOULD BREAK. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20891212 ↗
• MalfunctionNov 7, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C- SECTION PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, DURING THE OPERATION, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO USE, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAD HAPPENED IN THE NEWLY DISPENSED SUTURE WHEN IT WAS OPENED TO PREPARE FOR SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20632657 ↗
• MalfunctionNov 5, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT FEMORAL ENDARTERECTOMY WITH A LEFT FEMORAL-TIBIAL BYPASS PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURES STARTED TO DISSOLVE AS SOON AS IT WAS INTRODUCED TO THE TISSUE IN THE WOUND. TRIED TWO OR THREE FROM THE SAME BOX WITH THE SAME RESULTS. CASE WAS COMPLETED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20613806 ↗
• MalfunctionNov 5, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT FEMORAL ENDARTERECTOMY WITH A LEFT FEMORAL-TIBIAL BYPASS PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURES STARTED TO DISSOLVE AS SOON AS IT WAS INTRODUCED TO THE TISSUE IN THE WOUND. TRIED TWO OR THREE FROM THE SAME BOX WITH THE SAME RESULTS. CASE WAS COMPLETED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20613561 ↗
• MalfunctionNov 5, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT FEMORAL ENDARTERECTOMY WITH A LEFT FEMORAL-TIBIAL BYPASS PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURES STARTED TO DISSOLVE AS SOON AS IT WAS INTRODUCED TO THE TISSUE IN THE WOUND. TRIED TWO OR THREE FROM THE SAME BOX WITH THE SAME RESULTS. CASE WAS COMPLETED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20612146 ↗
• MalfunctionOct 26, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE TIP OF THE NEEDLE BROKE OFF DURING SKIN CLOSURE. FRAGMENT WAS RECOVERED. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20540120 ↗