PERMA-HAND SA87GRecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10705031050303), received between Aug 26, 2019 and Aug 13, 2025 — classified as 5 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Break” (22 reports).

8 other recalls cover devices cleared under the same FDA submission (K946173); they may or may not involve this specific model.

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 26 reports, in the reporter's own words as published by the FDA.

• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE PATIENT HAD COME TO THE HOSPITAL FOR SURGICAL TREATMENT DUE TO A TUMOR IN THE FOREARM. ON THE DAY OF ADMISSION, THE DOCTOR PERFORMED SURGICAL TREATMENT ON THE PATIENT AND SUTURED THE INCISION WITH SUTURE. ON THE FIRST DAY AFTER SURGERY, THE PATIENT WENT TO THE OUTPATIENT DEPARTMENT TO CHANGE THE DRESSING, COMPLAINING OF ITCHING AT THE SUTURE SITE. AFTER THE DOCTOR REMOVED IT, THE PATIENT'S SUTURE SITE WAS FOUND TO BE LOCALLY RED AND SWOLLEN, AND NO OBVIOUS SECRETIONS WERE FOUND. THE PATIENT HAD INFLAMMATION. THE PATIENT WAS GIVEN DRESSING CHANGES AND ORAL ANTIBIOTIC TREATMENT. THE PATIENT WAS ADVISED TO CLOSELY OBSERVE THE CONDITION OF THE INCISION AND SEEK MEDICAL ATTENTION IN A TIMELY MANNER IF THERE WERE ANY ISSUES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Inflammation; Itching Sensation; Swelling/ Edema

  MAUDE report 22793386 ↗
• MalfunctionDec 10, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CONTINUOUS EPIDURAL ANESTHESIA L2-3 PERFORMED VAGINAL TOTAL HYSTERECTOMY+ANTERIOR AND POSTERIOR VAGINAL WALL REPAIR+PARAVAGINAL REPAIR SURGERY ON (B)(6)2024 AND SUTURE WAS USED. DURING THE SURGERY, THE SUTURE BROKE WHEN THE LEFT UTEROSACRAL LIGAMENT AND CARDINAL LIGAMENT WERE CLAMPED AND THE POSTERIOR SUTURE WAS CUT. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20896427 ↗
• InjuryNov 18, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE FOR REMOVAL OF IMPACTED TEETH ON (B)(6) 2024 AND SUTURE WAS USED. DURING POSTOPERATIVE SUTURE TREATMENT, THE SUTURE BROKE. REPLACE THE SUTURE AND CONTINUE TREATMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20706856 ↗
• MalfunctionSep 20, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC LEFT SALPINGECTOMY UNDER GENERAL ANESTHESIA PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE PATIENT UNDERWENT SURGERY FOR "ECTOPIC PREGNANCY" AT 11:00. DURING THE SURGERY, THE DOCTOR USED GLOVES AND SUTURE TO MAKE A SPECIMEN BAG. WHEN TAKING THE SPECIMEN, THE SUTURE BROKE, CAUSING THE SPECIMEN TO SCATTER IN THE ABDOMINAL CAVITY AND AFFECTING THE PROGRESS OF THE SURGERY. THE SUTURE WAS IMMEDIATELY REPLACED AND THE SPECIMEN BAG WAS REMADE, AND THE SPECIMEN WAS SUCCESSFULLY REMOVED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20272961 ↗
• InjurySep 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE TO PROVIDE TREATMENT DUE TO LEG TRAUMA ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE DOCTOR CLEANED THE WOUND AND SUTURED THE WOUND WITH SUTURE. THE PATIENT WAS INSTRUCTED TO CHANGE DRESSING THE NEXT DAY AND CLOSELY OBSERVE THE CHANGES IN THE WOUND. ON THE SECOND DAY AFTER SURGERY, THE PATIENT CAME TO THE HOSPITAL FOR TREATMENT, COMPLAINING OF ITCHING AND REDNESS AT THE SUTURE SITE. IT WAS FOUND THAT THE PATIENT MAY BE ALLERGIC TO THE SUTURE AFTER DRESSING CHANGE. THE DOCTOR PROMPTLY ADMINISTERED ANTI ALLERGIC AND ANTI INFECTIVE DRUGS FOR TREATMENT, CLOSELY OBSERVED THE CHANGES IN THE PATIENT'S WOUND, AND SOUGHT MEDICAL ATTENTION IN A TIMELY MANNER IF NECESSARY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Hypersensitivity/Allergic reaction; Inflammation; Itching Sensation

  MAUDE report 20236732 ↗
• MalfunctionAug 14, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE KNOTTING PROCESS, THE SUTURE BROKE FOUR TIMES IN A ROW. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19981162 ↗
• MalfunctionAug 14, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON(B)(6)2024 AND SUTURE WAS USED. DURING THE KNOTTING PROCESS, THE SUTURE BROKE FOUR TIMES IN A ROW. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19981153 ↗
• MalfunctionAug 14, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE KNOTTING PROCESS, THE SUTURE BROKE FOUR TIMES IN A ROW. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19981145 ↗
• MalfunctionAug 14, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE KNOTTING PROCESS, THE SUTURE BROKE FOUR TIMES IN A ROW. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19981139 ↗
• MalfunctionJun 26, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN SKIN CLOSURE ON (B)(6)2024 AND SUTURE WAS USED.THE PATIENT WAS ADMITTED FOR TREATMENT AFTER DISCOVERING A BACK LUMP FOR OVER A MONTH. AFTER ADMISSION, RELEVANT EXAMINATIONS WERE COMPLETED AND SURGERY WAS REQUIRED TO SUTURE THE WOUND ON THE SKIN. THE KNOT WAS TIED AGAIN AND BROKE AGAIN. A NEW SUTURE WAS IMMEDIATELY REPLACED FOR SUTURING, AND THIS PHENOMENON DID NOT OCCUR AGAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19617986 ↗
• MalfunctionJun 26, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN SKIN CLOSURE ON (B)(6) 2024 AND SUTURE WAS USED. THE PATIENT WAS ADMITTED FOR TREATMENT AFTER DISCOVERING A BACK LUMP FOR OVER A MONTH. AFTER ADMISSION, RELEVANT EXAMINATIONS WERE COMPLETED AND SURGERY WAS REQUIRED TO SUTURE THE WOUND ON THE SKIN. AT 3:30 PM, WHEN THE DOCTOR WAS USING SUTURE TO TIE A KNOT ON THE WOUND, THE SUTURE BROKE. A NEW SUTURE WAS IMMEDIATELY REPLACED FOR SUTURING, AND THIS PHENOMENON DID NOT OCCUR AGAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19617566 ↗
• MalfunctionDec 18, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON 10/2/2023 AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED TO 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 18352810 ↗
• MalfunctionDec 6, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE WOUND REQUIRED DEBRIDEMENT AND SKIN SUTURING. WHEN THE DOCTOR WAS SUTURING THE WOUND, THE SUTURE SUDDENLY BROKE WHEN TYING A KNOT. THE SUTURE BROKE AGAIN WHEN TYING THE KNOT. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18276343 ↗
• MalfunctionOct 11, 2023Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE BROKEN WHEN THE LEFT SACRAL AND MAIN LIGAMENTS OF THE UTERUS WERE CLAMPED AND SUTURED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17915407 ↗
• MalfunctionJan 9, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A URETHRAL SUSPENSION+PELVIC FLOOR RECONSTRUCTION+VAGINAL WALL REPAIR+REPAIR OF OLD PERINEAL LACERATION PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE CENTRAL SUTURE AT THE UPPER END OF THE MESH WAS FIXED AT 1CM BELOW THE TRANSVERSE GROOVE OF THE URETHRA, AND THE LOWER END WAS FIXED AT BOTH SIDES OF THE PARA UTERINE TISSUES. THE REDUNDANT ANTERIOR VAGINAL WALL WAS TRIMMED, AND THE SUTURE WAS BROKEN WHEN SUTURING, RESULTING IN OOZING OF THE WOUND. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fluid Discharge

  MAUDE report 16126875 ↗
• MalfunctionJul 14, 2022Break; Defective Component; Break; Defective Component

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT SUTURE GOT SPLIT AND ROUGH IN THE SURGERY. CHANGED ANOTHER ONE TO COMPLETE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15022728 ↗
• MalfunctionJul 6, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT SUTURE BROKE DURING SEWING VAGINAL WALL IN SURGERY. THE PROCEDURE WAS VAGINAL HYSTERECTOMY + MODIFIED ANTERIOR PELVIC FLOOR SUSPENSION + MIDDLE URETHRAL SUSPENSION + PARAVAGINAL REPAIR + EXCISION OF POSTERIOR VAGINAL WALL VEGETATION. CHANGED ANOTHER TWO TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 14940685 ↗
• MalfunctionJul 6, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT SUTURE BROKE DURING SEWING VAGINAL WALL IN SURGERY. THE PROCEDURE WAS VAGINAL HYSTERECTOMY + MODIFIED ANTERIOR PELVIC FLOOR SUSPENSION + MIDDLE URETHRAL SUSPENSION + PARAVAGINAL REPAIR + EXCISION OF POSTERIOR VAGINAL WALL VEGETATION. CHANGED ANOTHER TWO TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 14940605 ↗
• MalfunctionJul 6, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT SUTURE BROKE DURING SEWING VAGINAL WALL IN SURGERY. THE PROCEDURE WAS VAGINAL HYSTERECTOMY + MODIFIED ANTERIOR PELVIC FLOOR SUSPENSION + MIDDLE URETHRAL SUSPENSION + PARAVAGINAL REPAIR + EXCISION OF POSTERIOR VAGINAL WALL VEGETATION. CHANGED ANOTHER TWO TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 14940596 ↗
• InjuryJun 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED FOR WOUND CLOSURE. THE PATIENT UNDERWENT SURGERY AT 15:23 P.M. AND THE DOCTOR SEW THE WOUND WITH SUTURE AT 15:50 P.M. AT 16:02 P.M. ON THE SECOND DAY AFTER SURGERY , THE PATIENT CAME TO HOSPITAL FOR DRESSING CHANGE AND FOUND THAT THE SKIN AT THE WOUND WAS RED AND SWOLLEN WITH INFLAMMATION. THE DOCTOR APPLIED COMPOUND DEXAMETHASONE CREAM AND WAITED FOR OBSERVATION. ON THE SECOND DAY, THE PATIENT'S SYMPTOMS WERE RELIEVED AND THE OINTMENT WAS APPLIED UNTIL THE STITCHING WAS REMOVED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Inflammation; Swelling/ Edema

  MAUDE report 14851531 ↗
• MalfunctionOct 19, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WOUND DEBRIDEMENT PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHILE SEWING. 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 12657738 ↗
• MalfunctionAug 30, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12385754 ↗
• MalfunctionMay 26, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RADICAL RESECTION OF RECTAL CANCER ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11888687 ↗
• MalfunctionJan 20, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A MIXED HEMORRHOID LIGATION ON (B)(6) 2020 AND THE SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BROKE DURING KNOTTING VESSEL RESULTING IN BLEEDING AT THE LIGATED BLOOD VESSEL. THE HEMOSTATIC FORCEPS WERE USED TO STOP BLEEDING. THEN ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11204855 ↗
• MalfunctionJan 22, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE FOR RECTAL CANCER ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN SEWING. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9616006 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K946173. One submission often covers many models, so check the product and lot details in each record.

• Z-1516-2025 · Mar 7, 2025 · Open, Classified
  ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH
• Z-1097-2025 · Dec 20, 2024 · Open, Classified
  PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovas
• Z-2486-2020 · Jun 10, 2020 · Open, Classified
  PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7983G FV768 FV769 FV7771 U7058 U7059 W1782 W1784 W1819 W1820 W818 W819 W870
• Z-1842-2019 · Apr 19, 2019 · Terminated
  ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX Product Code: X865W Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue appr
• Z-1841-2019 · Apr 19, 2019 · Terminated
  ETHIBOND EXCEL Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue app
• Z-0747-2019 · Dec 18, 2018 · Terminated
  PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Product Code 485T Product Usage: PERMA-HAND* suture is indicated for use in general soft tissue approxima
• Z-1839-2015 · May 8, 2015 · Terminated
  Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Surgical Suture, 5-0 (1.5 metric), 18" (45 cm), Conventional Cutting, Lot #JD6163, Exp: July 2019. Fast ab
• Z-0492-2015 · Oct 17, 2014 · Terminated
  Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA.