PDS PDP311HRecalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10705031048003), received between Aug 22, 2018 and Aug 20, 2025 — classified as 3 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Break” (27 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 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC TRAUMA SURGERY IN (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW MUSCLES. TOTAL 3 PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. THERE WILL RETURN 3 ACTUAL PRODUCTS AND 33 REPRESENTATIVE SAMPLES FOR ANALYSIS. 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 22849246 ↗
• MalfunctionAug 20, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC TRAUMA SURGERY IN JULY 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW MUSCLES. TOTAL 3 PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE . CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. THERE WILL RETURN 3 ACTUAL PRODUCTS AND 33 REPRESENTATIVE SAMPLES FOR ANALYSIS . 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 22849244 ↗
• MalfunctionAug 20, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC TRAUMA SURGERY IN JULY 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW MUSCLES. TOTAL 3 PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. THERE WILL RETURN 3 ACTUAL PRODUCTS AND 33 REPRESENTATIVE SAMPLES FOR ANALYSIS. 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 22849220 ↗
• MalfunctionAug 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW MUSCLES. TOTAL 3 PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. THERE WILL RETURN 3 ACTUAL PRODUCTS AND 32 REPRESENTATIVE SAMPLES FOR ANALYSIS. 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 22840919 ↗
• MalfunctionAug 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE IN JULY 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW MUSCLES. TOTAL 3 PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. THERE WILL RETURN 3 ACTUAL PRODUCTS AND 32 REPRESENTATIVE SAMPLES FOR ANALYSIS. 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 22840913 ↗
• MalfunctionAug 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW MUSCLES. TOTAL 3 PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. THERE WILL RETURN 3 ACTUAL PRODUCTS AND 32 REPRESENTATIVE SAMPLES FOR ANALYSIS. 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 22840909 ↗
• MalfunctionAug 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC TRAUMA SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW MUSCLES. TOTAL 4 PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THERE WILL RETURN 4 ACTUAL PRODUCTS AND 67 REPRESENTATIVE SAMPLES FOR ANALYSIS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22840374 ↗
• MalfunctionAug 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC TRAUMA SURGERY IN (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW MUSCLES. TOTAL 4 PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THERE WILL RETURN 4 ACTUAL PRODUCTS AND 67 REPRESENTATIVE SAMPLES FOR ANALYSIS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22840354 ↗
• MalfunctionAug 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC TRAUMA SURGERY IN (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW MUSCLES. TOTAL 4 PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THERE WILL RETURN 4 ACTUAL PRODUCTS AND 67 REPRESENTATIVE SAMPLES FOR ANALYSIS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22840340 ↗
• MalfunctionAug 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC TRAUMA SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW MUSCLES. TOTAL 4 PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THERE WILL RETURN 4 ACTUAL PRODUCTS AND 67 REPRESENTATIVE SAMPLES FOR ANALYSIS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22840313 ↗
• MalfunctionJul 25, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INTERNAL FIXATION SURGERY FOR A FRACTURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN WHEN THE SURGEON WAS SUTURING THE MUSCLE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22609548 ↗
• MalfunctionJul 25, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INTERNAL FIXATION SURGERY FOR A FRACTURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN WHEN THE SURGEON WAS SUTURING THE MUSCLE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22609454 ↗
• MalfunctionJul 23, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A INTERNAL FIXATION SURGERY FOR FRACTURES PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON WAS SUTURING THE MUSCLE. TWO PRODUCTS HAVE SAME ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE INTERNAL FIXATION SURGERY FOR FRACTURES SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22575749 ↗
• MalfunctionJul 23, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INTERNAL FIXATION SURGERY FOR FRACTURES PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON WAS SUTURING THE MUSCLE. TWO PRODUCTS HAVE SAME ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE INTERNAL FIXATION SURGERY FOR FRACTURES SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22575735 ↗
• MalfunctionJul 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY AFTER THE NEEDLE WAS PASSED THROUGH THE TISSUE. THIS EVENT WAS FOUND BEFORE USE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22542393 ↗
• MalfunctionJun 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. THE PRODUCT WAS USED ON THE KNEES. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22330175 ↗
• MalfunctionMar 26, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OPEN CARDIOVASCULAR SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WHICH WAS USED FOR SUBCUTANEOUS SUTURING OF CLOSED-CHEST, WAS DETACHED WITH SUTURING. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21696273 ↗
• MalfunctionMar 26, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OPEN CARDIOVASCULAR SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WHICH WAS USED FOR SUBCUTANEOUS SUTURING OF CLOSED-CHEST, WAS DETACHED WITH SUTURING. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21696271 ↗
• MalfunctionNov 25, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20774693 ↗
• MalfunctionSep 20, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS NOT A CONTROL RELEASE NEEDLE. THE NEEDLE HAD BEEN DETACHED FROM THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20270794 ↗
• MalfunctionFeb 22, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PYELOPLASTY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED THAT THE SUTURE WAS FOUND BROKEN WHEN IT WAS OPENED TO PREPARE FOR THE SURGERY. 3 PRODUCTS HAVE SAME ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. VISUAL INSPECTION WAS CONDUCTED ON THE RETURNED DEVICE. THE RETURNED SAMPLE DETERMINED THAT IT WAS RECEIVED ONE OPEN SAMPLE THAT PERTAINED TO PRODUCT CODE PDP311H. UPON VISUAL ASSESSMENT OF THE RETURNED SAMPLE, IT WAS OBSERVED THAT THE STRAND HAD BEGUN WITH A DEGRADATION PROCESS CAUSED BY EXPOSURE TO THE ENVIRONMENT. THE FOIL WAS VISUALLY INSPECTED, AND WRINKLES AND HOLES IN THE CAVITY WERE OBSERVED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18759179 ↗
• MalfunctionFeb 22, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PYELOPLASTY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED THAT THE SUTURE WAS FOUND BROKEN WHEN IT WAS OPENED TO PREPARE FOR THE SURGERY. 3 PRODUCTS HAVE SAME ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. VISUAL INSPECTION WAS CONDUCTED ON THE RETURNED DEVICE. THE RETURNED SAMPLE DETERMINED THAT IT WAS RECEIVED ONE OPEN SAMPLE THAT PERTAINED TO PRODUCT CODE PDP311H. UPON VISUAL ASSESSMENT OF THE RETURNED SAMPLE, IT WAS OBSERVED THAT THE STRAND HAD BEGUN WITH A DEGRADATION PROCESS CAUSED BY EXPOSURE TO THE ENVIRONMENT. THE FOIL WAS VISUALLY INSPECTED, AND WRINKLES AND HOLES IN THE CAVITY WERE OBSERVED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18759178 ↗
• MalfunctionFeb 22, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PYELOPLASTY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED THAT THE SUTURE WAS FOUND BROKEN WHEN IT WAS OPENED TO PREPARE FOR THE SURGERY. 3 PRODUCTS HAVE SAME ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. VISUAL INSPECTION WAS CONDUCTED ON THE RETURNED DEVICE. THE RETURNED SAMPLE DETERMINED THAT IT WAS RECEIVED ONE OPEN SAMPLE THAT PERTAINED TO PRODUCT CODE PDP311H. UPON VISUAL ASSESSMENT OF THE RETURNED SAMPLE, IT WAS OBSERVED THAT THE STRAND HAD BEGUN WITH A DEGRADATION PROCESS CAUSED BY EXPOSURE TO THE ENVIRONMENT. THE FOIL WAS VISUALLY INSPECTED, AND WRINKLES AND HOLES IN THE CAVITY WERE OBSERVED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18759168 ↗
• MalfunctionNov 14, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT UNKNOWN OB-GYN SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. DURING AN UNKNOWN OB-GYN SURGERY, THE NEEDLE TIP WAS BROKEN DURING USE AND IT WAS REMOVED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18131457 ↗
• MalfunctionNov 8, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, AT 17:00 DURING THE SURGERY, WHEN THE DOCTOR SUTURED THE PATIENT'S MUSCLES, THE SUTURE NEEDLE AT THE FRONT END OF THE SUTURE BROKE INTO THE MUSCLE, AND REPEATED SEARCHES SHOWED NO SIGNS. USING AN X-RAY ARM MACHINE FOR FLUOROSCOPY, IT WAS DETERMINED THAT IT WAS INSIDE THE INCISION MUSCLE. UNDER THE X-RAY ARM MACHINE FOR FLUOROSCOPY, THE BROKEN END OF THE NEEDLE WAS FOUND AND REMOVED. RESTITCH MUSCLE TISSUE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18091647 ↗