Coated VICRYL J945HRecalls & reported problems
Johnson & Johnson International Inc. · Undyed Braided (Polyglactin 910), Synthetic Absorbable Suture · Class 2 · Implant
All models of Coated VICRYL (50)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Coated VICRYL J945H is a synthetic absorbable surgical suture from Johnson & Johnson used to close tissue. The 62 reports mostly describe the thread separating from the needle or breaking mid-procedure, and a few mention the suture arriving unsterile or discolored. Seven reports involved injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 61
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 10705031043657), received between Jul 11, 2019 and May 27, 2026 — classified as 7 injuries, 54 malfunctions.
The most frequently reported specific device problem is “Material Separation” (30 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.
Reports received per month
Most reported problems
Device problems
- Material Separation30
- Break19
- Adverse Event Without Identified Device or Use Problem5
- Delivered as Unsterile Product5
- Device Contaminated During Manufacture or Shipping2
- Material Discolored1
Patient problems
- No Clinical Signs, Symptoms or Conditions46
- No Consequences Or Impact To Patient9
- Wound Dehiscence4
- Erythema3
- Inflammation3
- Pain2
- Swelling/ Edema2
- Abscess1
Recent adverse event reports
The 25 most recent of 61 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 27, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT DURING A TOTAL KNEE REPLACEMENT PROCEDURE, THE SUTURE REPEATEDLY DETACHED FROM THE NEEDLE DURING USE, INVOLVING FOUR SUTURES. DEVICE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25301699 ↗MalfunctionMay 27, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT DURING A TOTAL KNEE REPLACEMENT PROCEDURE, THE SUTURE REPEATEDLY DETACHED FROM THE NEEDLE DURING USE, INVOLVING FOUR SUTURES. DEVICE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25301302 ↗MalfunctionMay 27, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT DURING A TOTAL KNEE REPLACEMENT PROCEDURE, THE SUTURE REPEATEDLY DETACHED FROM THE NEEDLE DURING USE, INVOLVING FOUR SUTURES. DEVICE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25301294 ↗MalfunctionMay 27, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT DURING A TOTAL KNEE REPLACEMENT PROCEDURE, THE SUTURE REPEATEDLY DETACHED FROM THE NEEDLE DURING USE, INVOLVING FOUR SUTURES. DEVICE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25301291 ↗MalfunctionMay 22, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT DURING A TOTAL KNEE REPLACEMENT PROCEDURE, THE SUTURE REPEATEDLY DETACHED FROM THE NEEDLE DURING USE, INVOLVING FOUR SUTURES. NO PATIENT CONSEQUENCES WERE REPORTED. DEVICE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25256356 ↗MalfunctionMay 22, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT DURING A TOTAL KNEE REPLACEMENT PROCEDURE, THE SUTURE REPEATEDLY DETACHED FROM THE NEEDLE DURING USE, INVOLVING FOUR SUTURES. NO PATIENT CONSEQUENCES WERE REPORTED. DEVICE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25256294 ↗MalfunctionApr 9, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT THE SUTURE WAS BEING USED, THE NEEDLE BEGAN BENDING AND EVENTUALLY BROKE AS THEY ATTEMPTED TO SECURE IT. DEVICE AVAILABILITY UNKNOWN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24832711 ↗MalfunctionApr 7, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE ACCOUNT CONTACT TO THE SALES REP THAT WHILE SUTURING THE TIP OF THE NEEDLE BENT. WHEN THE PHYSICIAN WENT TO STRAIGHTEN IT, THE TIP OF THE SUTURE BROKE OFF. NO BROKEN NEEDLES FOUND IN PATIENT'S BODY SO NO PATIENT CONSEQUENCES. DEVICE IS RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24808986 ↗MalfunctionDec 30, 2025Material Discolored; Device Contaminated During Manufacture or Shipping; Material Discolored; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE, THE COLOR OF THE NEEDLE WAS BLACK NOT SILVER. THE SALES REP STATED IT WAS ALSO RUSTY. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23923978 ↗MalfunctionAug 5, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UROLOGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE CLIPS WERE USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN UROLOGICAL SURGERY, THE OPENED PRODUCTS HAD ALREADY BEEN HYDROLYZED. THERE WERE INSTANCES WHERE NEWLY OPENED CLIPS COULD BE LOADED, BUT THERE WERE ALSO CASES WHERE THE NEWLY OPENED ONES HAD ALSO BEEN HYDROLYZED. WHEN TOUCHED, THEY CRUMBLED AND BROKE APART, SO ONLY SOME OF THE PACKAGES RELATED TO THE COMPLAINT HAVE BEEN KEPT. (MANY OF THE XC200 CLIPS HAVE LOST THEIR ORIGINAL FORM AND HAVE BEEN DISCARDED. SOME OF THE PACKAGES HAVE ALSO BEEN DISCARDED.) AS FOR THE COMPLAINT ITEM, THE XC200 HAS ALREADY BEEN DISCARDED, SO ONLY THE PACKAGE STORED WILL BE RETURNED. THE CUSTOMER WOULD LIKE TO ASK YOU TO CHECK FOR PINHOLES. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ONE DEVICE WILL BE RETURNING. NO FURTHER INFORMATION IS AVAILABLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22717567 ↗MalfunctionAug 5, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN UROLOGICAL SURGERY, THE OPENED PRODUCTS HAD ALREADY BEEN HYDROLYZED. THERE WERE INSTANCES WHERE NEWLY OPENED CLIPS COULD BE LOADED, BUT THERE WERE ALSO CASES WHERE THE NEWLY OPENED ONES HAD ALSO BEEN HYDROLYZED. WHEN TOUCHED, THEY CRUMBLED AND BROKE APART, SO ONLY SOME OF THE PACKAGES RELATED TO THE COMPLAINT HAVE BEEN KEPT. (MANY OF THE XC200 CLIPS HAVE LOST THEIR ORIGINAL FORM AND HAVE BEEN DISCARDED. SOME OF THE PACKAGES HAVE ALSO BEEN DISCARDED.) AS FOR THE COMPLAINT ITEM, THE XC200 HAS ALREADY BEEN DISCARDED, SO ONLY THE PACKAGE STORED WILL BE RETURNED. THE CUSTOMER WOULD LIKE TO ASK YOU TO CHECK FOR PINHOLES. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ONE DEVICE WILL BE RETURNING. NO FURTHER INFORMATION IS AVAILABLE. AFFILIATE REFERENCE NUMBER: (B)(4). PLEASE TAKE PHOTOS FOR JAPANESE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22717566 ↗MalfunctionAug 5, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UROLOGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE CLIPS WERE USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN UROLOGICAL SURGERY, THE OPENED PRODUCTS HAD ALREADY BEEN HYDROLYZED. THERE WERE INSTANCES WHERE NEWLY OPENED CLIPS COULD BE LOADED, BUT THERE WERE ALSO CASES WHERE THE NEWLY OPENED ONES HAD ALSO BEEN HYDROLYZED. WHEN TOUCHED, THEY CRUMBLED AND BROKE APART, SO ONLY SOME OF THE PACKAGES RELATED TO THE COMPLAINT HAVE BEEN KEPT. (MANY OF THE XC200 CLIPS HAVE LOST THEIR ORIGINAL FORM AND HAVE BEEN DISCARDED. SOME OF THE PACKAGES HAVE ALSO BEEN DISCARDED.) AS FOR THE COMPLAINT ITEM, THE XC200 HAS ALREADY BEEN DISCARDED, SO ONLY THE PACKAGE STORED WILL BE RETURNED. THE CUSTOMER WOULD LIKE TO ASK YOU TO CHECK FOR PINHOLES. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ONE DEVICE WILL BE RETURNING. NO FURTHER INFORMATION IS AVAILABLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22717564 ↗MalfunctionAug 5, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UROLOGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE CLIPS WERE USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN UROLOGICAL SURGERY, THE OPENED PRODUCTS HAD ALREADY BEEN HYDROLYZED. THERE WERE INSTANCES WHERE NEWLY OPENED CLIPS COULD BE LOADED, BUT THERE WERE ALSO CASES WHERE THE NEWLY OPENED ONES HAD ALSO BEEN HYDROLYZED. WHEN TOUCHED, THEY CRUMBLED AND BROKE APART, SO ONLY SOME OF THE PACKAGES RELATED TO THE COMPLAINT HAVE BEEN KEPT. (MANY OF THE XC200 CLIPS HAVE LOST THEIR ORIGINAL FORM AND HAVE BEEN DISCARDED. SOME OF THE PACKAGES HAVE ALSO BEEN DISCARDED.) AS FOR THE COMPLAINT ITEM, THE XC200 HAS ALREADY BEEN DISCARDED, SO ONLY THE PACKAGE STORED WILL BE RETURNED. THE CUSTOMER WOULD LIKE TO ASK YOU TO CHECK FOR PINHOLES. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ONE DEVICE WILL BE RETURNING. NO FURTHER INFORMATION IS AVAILABLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22717562 ↗MalfunctionAug 5, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UROLOGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE CLIPS WERE USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN UROLOGICAL SURGERY, THE OPENED PRODUCTS HAD ALREADY BEEN HYDROLYZED. THERE WERE INSTANCES WHERE NEWLY OPENED CLIPS COULD BE LOADED, BUT THERE WERE ALSO CASES WHERE THE NEWLY OPENED ONES HAD ALSO BEEN HYDROLYZED. WHEN TOUCHED, THEY CRUMBLED AND BROKE APART, SO ONLY SOME OF THE PACKAGES RELATED TO THE COMPLAINT HAVE BEEN KEPT. (MANY OF THE XC200 CLIPS HAVE LOST THEIR ORIGINAL FORM AND HAVE BEEN DISCARDED. SOME OF THE PACKAGES HAVE ALSO BEEN DISCARDED.) AS FOR THE COMPLAINT ITEM, THE XC200 HAS ALREADY BEEN DISCARDED, SO ONLY THE PACKAGE STORED WILL BE RETURNED. THE CUSTOMER WOULD LIKE TO ASK YOU TO CHECK FOR PINHOLES. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ONE DEVICE WILL BE RETURNING. NO FURTHER INFORMATION IS AVAILABLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22717525 ↗MalfunctionAug 5, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT TIP OF THE NEEDLE IS BREAKING OFF FREQUENTLY. SURGICAL DELAY WAS UNKNOWN. NO PATIENT HARM WAS THERE. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22713860 ↗MalfunctionAug 5, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT TIP OF THE NEEDLE IS BREAKING OFF FREQUENTLY. SURGICAL DELAY WAS UNKNOWN. NO PATIENT HARM WAS THERE. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22713804 ↗MalfunctionAug 5, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT TIP OF THE NEEDLE IS BREAKING OFF FREQUENTLY. SURGICAL DELAY WAS UNKNOWN. NO PATIENT HARM WAS THERE. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22713802 ↗MalfunctionAug 5, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT TIP OF THE NEEDLE IS BREAKING OFF FREQUENTLY. SURGICAL DELAY WAS UNKNOWN. NO PATIENT HARM WAS THERE. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22713801 ↗MalfunctionAug 5, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT TIP OF THE NEEDLE IS BREAKING OFF FREQUENTLY. SURGICAL DELAY WAS UNKNOWN. NO PATIENT HARM WAS THERE. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22713800 ↗MalfunctionAug 5, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT TIP OF THE NEEDLE IS BREAKING OFF FREQUENTLY. SURGICAL DELAY WAS UNKNOWN. NO PATIENT HARM WAS THERE. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22713687 ↗MalfunctionApr 18, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY THE CUSTOMER THAT THE "VICRYL 2.0 CT-1 SUTURE NEEDLE WAS RUSTY LOOKING, SEEMS LIKE COATING WAS SCRAPED OFF". DEVICE DID NOT COME INTO A CONTACT WITH THE PATIENT. NO DELAY IN THE PROCEDURE REPORTED. NO OTHER DETAILS PROVIDED. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21865224 ↗InjuryOct 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY PROCEDURE IN (B)(6) 2023 AND RUNNING SUTURE WAS USED ON THE VAGINAL CUFF. THE PATIENT EXPERIENCED A VAGINAL CUFF DEHISCENCE. THE PATIENT WAS TAKEN BACK TO SURGERY AND THE CUFF WAS CLOSED LAPAROSCOPICALLY ON (B)(6) 2023 OR IN OCTOBER. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Wound Dehiscence
MAUDE report 17951866 ↗InjuryAug 29, 2023Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST OPERATIVELY, THE SUTURES BROKE AND THE WOUND DEHISCED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Wound Dehiscence
MAUDE report 17641847 ↗InjuryAug 29, 2023Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST OPERATIVELY, THE SUTURES BROKE AND THE WOUND DEHISCED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Wound Dehiscence
MAUDE report 17641845 ↗MalfunctionMay 9, 2023Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING AN ORTHOPEDIC PROCEDURE SEVERAL SUTURES BROKE OFF OF THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16895442 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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