PDS PDP509GRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10705031207240), received between Jun 7, 2019 and May 4, 2026 — classified as 2 injuries, 14 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 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 A SALES REP THAT, DURING AN UNKNOWN SURGERY, THE NEEDLE WAS BROKEN DURING USE AND USE WAS STOPPED. NO PIECES WERE LEFT INSIDE THE PATIENT. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. 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 25073286 ↗
• MalfunctionDec 16, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THE NEEDLE COULD NOT BE PASSED THROUGH FROM THE FIRST STITCH. IT COULD BE CONSIDERED THAT THE NEEDLE TIP WAS BROKEN. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. 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 23821096 ↗
• MalfunctionNov 13, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS BROKEN DURING USE. IT IS UNKNOWN WHAT SURGERY PERFORMED. AFTER RECEIVING THE PRODUCT, WHEN THE SALES REP CHECKED IT, HE SPECULATES THAT THE SUTURE WAS DETACHED RATHER THAN THE NEEDLE BREAKAGE. IT WAS NOT A CONTROL RELEASE NEEDLE. 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 23542755 ↗
• InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED FOR FACIAL SUTURING. THE SUTURE WAS USED FOR BURIED SUTURE, AND THE USED SITE WAS REINFORCED WITH TAPING. POST-OP, AFTER APPROXIMATELY 3 MONTHS, THE SUTURE WAS PARTLY PROTRUDED AS IF A REACTION OF FOREIGN MATTER, SO WHEN THE SUTURE WAS REMOVED WITH THE PATIENT'S AGREEMENT, THE WOUND WAS OPENED. THE OPEN WOUND WAS SUTURED AND TREATED WITH ANOTHER NYLON SUTURE, BUT IT WAS A SERIOUS EXPERIENCE FOR BOTH THE PATIENT AND THE DOCTOR. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. THE PATIENT HAS BEEN DISCHARGED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body Reaction; Impaired Healing; Pocket Erosion; Wound Dehiscence

  MAUDE report 21358643 ↗
• InjuryFeb 6, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN SUTURING THE DERMIS ON WOUND CLOSURE, THE NEEDLE BECAME DETACHED FROM THE SUTURE ON THE WAY AND THE NEEDLE WAS LOST IN SIGHT. THE SURGEON THOUGHT THAT THE NEEDLE FELL OUT OF THE SURGICAL FIELD INSTEAD OF INSIDE THE BODY, SO THE SURGEON PROCEEDED TO SUTURE THE WOUND WITH A NEW NEEDLE, WHILE LOOKING OUT FOR THE FALLEN NEEDLE. AFTER COMPLETING THE SUTURE, THERE WAS ALSO NO NEEDLE IN SIGHT, SO AN X-RAY WAS PERFORMED. A SHADOW THAT LOOKED AS IF THE NEEDLE WAS INSIDE THE BODY WAS SEEN, AND ADDITIONAL FLUOROSCOPY WAS PERFORMED. AFTER FLUOROSCOPY, THE NEEDLE WAS CONFIRMED TO BE INSIDE THE BODY, SO WHEN THE WOUND WAS OPENED AGAIN, THE NEEDLE WAS FOUND TO HAVE FALLEN INTO THE SUBCUTANEOUS AREA AND IT WAS REMOVED. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. THE EFFECT ON THE PATIENT WAS THE RISK OF A SMALL AMOUNT OF EXPOSURE DUE TO ADDITIONAL FLUOROSCOPY, AND AN INCREASE OF THE ENTIRE BODY LOAD DUE TO THE EXTENSION OF THE OPERATION TIME BY ABOUT 1 HOUR AND HALF. ADDITIONAL INFORMATION AS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21325217 ↗
• MalfunctionApr 3, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY ON (B)(6) 2024, AND SUTURE WAS USED ON THE DERMIS. DURING SURGERY, WHEN PULLING THE SUTURE DURING LIGATION, IT WAS BROKEN. IT WAS USED WITH THE USUAL WAY. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19034531 ↗
• MalfunctionJun 22, 2023Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17181243 ↗
• MalfunctionMay 9, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED FROM THE ANALYSIS OF THE RETURNED PRODUCT THAT NEEDLE BREAKAGE OCCURRED, A FRACTURE WAS OBSERVED NEAR THE TIP AND THROUGH THE BODY OF THE NEEDLE. IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. IT WAS FOUND THAT THE NEEDLE TIP HAD BEEN BENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16898444 ↗
• MalfunctionJan 11, 2023Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16135656 ↗
• MalfunctionNov 9, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN THE SURGEON TRIED TO USE THE PRODUCT, IT WAS FOUND THAT THE NEEDLE WAS ALREADY DETACHED FROM THE SUTURE FROM THE BEGINNING. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. A FRACTURE WAS OBSERVED AT THE SUTURE ATTACHMENT OF THE NEEDLE DURING DEVICE ANALYSIS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15759912 ↗
• MalfunctionAug 17, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY DURING CONTINUOUS SUTURING. IT WAS NOT A CONTROL RELEASE NEEDLE. THE PRODUCT WAS DISCARDED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15244396 ↗
• MalfunctionApr 25, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. WHEN PUTTING THE FIRST STITCH WITH THE USUAL WAY, THE NEEDLE TIP WAS BROKEN. THE BROKEN FRAGMENT WAS CONFIRMED VISUALLY AND IT WAS RETRIEVED. THERE WAS NO POSSIBILITY OF INTERNAL REMNANT. THE OPERATION TIME WAS NOT EXTENDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14193953 ↗
• MalfunctionFeb 13, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OB-GYN PROCEDURE ON AN UNKNOWN DATE AND THE SUTURE WAS USED. IT WAS REPORTED THAT DURING SURGERY, THE SURGEON HELD THE NEEDLE WITH A NEEDLE-HOLDER, THE NEEDLE WAS BROKEN EASILY AT THE SWAGE PART THOUGH NO EXTRA FORCE WAS APPLIED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9708982 ↗
• MalfunctionOct 31, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A BREAST CONSERVATION SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. THE SURGEON FELT THAT THE NEEDLE BECAME DULL WHILE HE WAS DOING INTERRUPTED SUTURING BY INSTRUMENT TYING. WHEN HE CHECKED THE NEEDLE TIP, IT WAS FOUND THAT THE NEEDLE TIP HAD BEEN BROKEN. THE BROKEN NEEDLE TIP COULD NOT BE FOUND ON THE SURGICAL FIELD NOR THE INSTRUMENT TABLE. IT COULD NOT BE FOUND ON X-RAY IMAGES, NEITHER. SO, THE SURGERY WAS COMPLETED WITHOUT FINDING THE BROKEN NEEDLE TIP. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PATIENT HAS BEEN DISCHARGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient

  MAUDE report 9261150 ↗
• MalfunctionSep 19, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC SURGERY ON UNKNOWN DATE AND THE SUTURE WAS USED. DURING THE SURGERY, THE NEEDLE TIP WAS BROKEN DURING USE THOUGH IT WAS USED IN USUAL WAY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9086167 ↗
• MalfunctionJun 7, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE IN 2019 AND SUTURE WAS USED. THE SUTURE BROKE DURING USE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8680692 ↗