PDS Z508GRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10705031061316), received between Dec 11, 2018 and Dec 12, 2024 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SKIN VALVE FORMATION PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING SURGERY THE NEEDLE TIP WAS BROKEN. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20920048 ↗
• MalfunctionJun 9, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT UNKNOWN PLASTIC SURGERY ON (B)(6)2023 AND SUTURE WAS USED. SOME NEEDLES WERE BROKEN AT THE MIDDLE PART DURING INTERRUPTED SUTURE ON DERMIS. AFTER THAT, SOME NEEDLES WERE BROKEN AT THE NEEDLE TIP PART. THIS HAPPENED IN 5 NEEDLES IN TOTAL. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17099641 ↗
• MalfunctionJun 9, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT UNKNOWN PLASTIC SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. SOME NEEDLES WERE BROKEN AT THE MIDDLE PART DURING INTERRUPTED SUTURE ON DERMIS. AFTER THAT, SOME NEEDLES WERE BROKEN AT THE NEEDLE TIP PART. THIS HAPPENED IN 5 NEEDLES IN TOTAL. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17099474 ↗
• MalfunctionJun 9, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT UNKNOWN PLASTIC SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. SOME NEEDLES WERE BROKEN AT THE MIDDLE PART DURING INTERRUPTED SUTURE ON DERMIS. AFTER THAT, SOME NEEDLES WERE BROKEN AT THE NEEDLE TIP PART. THIS HAPPENED IN 5 NEEDLES IN TOTAL. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17099461 ↗
• MalfunctionJun 9, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT UNKNOWN PLASTIC SURGERY ON (B)(6)2023 AND SUTURE WAS USED. SOME NEEDLES WERE BROKEN AT THE MIDDLE PART DURING INTERRUPTED SUTURE ON DERMIS. AFTER THAT, SOME NEEDLES WERE BROKEN AT THE NEEDLE TIP PART. THIS HAPPENED IN 5 NEEDLES IN TOTAL. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17099448 ↗
• MalfunctionJun 9, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT UNKNOWN PLASTIC SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. SOME NEEDLES WERE BROKEN AT THE MIDDLE PART DURING INTERRUPTED SUTURE ON DERMIS. AFTER THAT, SOME NEEDLES WERE BROKEN AT THE NEEDLE TIP PART. THIS HAPPENED IN 5 NEEDLES IN TOTAL. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17099447 ↗
• MalfunctionDec 20, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. THE NEEDLE HAD BEEN BROKEN AT THE SWAGE PART. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13049943 ↗
• MalfunctionSep 21, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. BEFORE USE ON PATIENT, IT WAS FOUND THAT THE SWAGE PART OF THE NEEDLE BROKE INTO 2 PIECES VERTICALLY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12508677 ↗
• MalfunctionJun 21, 2021Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PEDIATRIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED OFF THE NEEDLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE EVENTS OR PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12032090 ↗
• MalfunctionAug 5, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN DURING USE, SO USE WAS STOPPED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10370162 ↗
• MalfunctionJan 4, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SKIN GRAFT SURGERY PROCEDURE ON (B)(6) 2018 AND A SUTURE WAS USED. DURING SURGERY, A NEEDLE TIP WAS FOUND IN THE PATIENT¿S BODY WHEN CLOSING THE WOUND BY INTERRUPTED SUTURING. THE NEEDLE TIP WAS RETRIEVED. THERE WAS NO EXTENSION OF THE OPERATION TIME. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8219445 ↗
• MalfunctionDec 11, 2018Material Separation; Tear, Rip or Hole in Device Packaging; Material Separation; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PLASTIC SURGERY ON (B)(6) 2018, AND SUTURE WAS USED. PRIOR TO USE ON THE PATIENT, THE SUTURE WAS EASILY DETACHED FROM THE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. UPON DEVICE EVALUATION, THE FOIL WAS EXAMINED FOR VISUAL INSPECTION AND PRESENT HOLES IN CAVITY ON THE BACK- FOIL PACKAGE DUE TO EXCESSIVE MANIPULATION AND THIS CONDITION CONTRIBUTED TO DEGRADATION OF THE SUTURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8150691 ↗
• MalfunctionDec 11, 2018Material Separation; Tear, Rip or Hole in Device Packaging; Material Separation; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PLASTIC SURGERY ON (B)(6) 2018, AND SUTURE WAS USED. PRIOR TO USE ON THE PATIENT, THE SUTURE WAS EASILY DETACHED FROM THE NEEDLE WHEN TAKING OUT A NEEDLE FROM THE TRAY BY HOLDING IT WITH A NEEDLE-HOLDER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. UPON DEVICE EVALUATION, THE FOIL WAS EXAMINED FOR VISUAL INSPECTION AND PRESENT HOLES IN CAVITY ON THE BACK- FOIL PACKAGE DUE TO EXCESSIVE MANIPULATION AND THIS CONDITION CONTRIBUTED TO DEGRADATION OF THE SUTURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8150678 ↗