PERMA-HAND K833HRecalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10705031044388), received between May 17, 2018 and May 26, 2026 — classified as 1 injury, 45 malfunctions.

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

1 FDA recall record name this device's identifier, 1 still open.

7 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.

Recalls naming this device

1. Dec 20, 2024Open, Classified

   Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.

   Z-1097-2025 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE BROKE OFF FROM THE THREAD. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25281447 ↗
• MalfunctionMar 10, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THE NEEDLES KEPT POPPING OFF THE SWEDGE. DEVICES ARE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24559271 ↗
• MalfunctionOct 31, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE SURGEON WAS ALERTED BY THE SERVICE LINE LEAD AND THE RESIDENT THAT DR. EXPERIENCED A SUTURE, WHERE THE NEEDLE PREMATURELY POPPED OFF THE THREAD. THE PROCEDURE WAS DELAYED BY FIFTEEN MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23442761 ↗
• MalfunctionAug 14, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE, THE NEEDLED BROKE WHILE SUTURING. THE NEEDLE WAS FOUND. 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 22810037 ↗
• MalfunctionOct 2, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING USE ON A PATIENT THE NEEDLE BROKE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20353414 ↗
• MalfunctionSep 11, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, PLACED SUTURE DOWN A TROCAR DURING SURGERY AND THE NEEDLE POPPED OFF. SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20192032 ↗
• MalfunctionAug 7, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, CLOSING AND FINAL COUNTS WERE COMPLETED AND CORRECT. THE SURGEON SUTURED THE PATIENT'S HEMOVAC DRAIN AFTER SKIN CLOSURE. UPON SUTURING THE DRAIN, THE ATRAUMATIC FROM THE DRAIN SUTURE SNAPPED OFF. ATRAUMATIC IS NOT SECURED IN THE NEEDLE DRIVER AND FLEW OFF THE STERILE FIELD. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19928046 ↗
• MalfunctionJan 26, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINAL CLOSURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON WAS SUTURING INTRA ABDOMINALLY, AND THE NEEDLE FELL OFF OF THE SUTURE WHEN THE SURGEON WAS PULLING THE SUTURE STRAND THROUGH THE TISSUE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18586873 ↗
• MalfunctionJan 26, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINAL CLOSURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON WAS SUTURING INTRA ABDOMINALLY, AND THE NEEDLE FELL OFF OF THE SUTURE WHEN THE SURGEON WAS PULLING THE SUTURE STRAND THROUGH THE TISSUE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18586872 ↗
• MalfunctionJan 26, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINAL CLOSURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON WAS SUTURING INTRA ABDOMINALLY, AND THE NEEDLE FELL OFF OF THE SUTURE WHEN THE SURGEON WAS PULLING THE SUTURE STRAND THROUGH THE TISSUE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18586871 ↗
• MalfunctionJan 3, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SLEEVE GASTRECTOMY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY WITH HIATAL HERNIA REPAIR PROCEDURE THAT THE SCRUB TECH HANDED OFF THE SUTURE TO THE DR TO GO INTO THE 8MM TROCAR THAT AFTER THE SUTURE WAS PULLED THROUGH THERE WAS NO NEEDLE ON THE SUTURE. AN X-RAY WAS DONE AND SHOWED THE NEEDLE POSSIBLY NEXT TO THE SPLEEN. AFTER THE X-RAY BUT BEFORE CLOSURE THE NEEDLE WAS FOUND IN THE CLEAR CANULA OF THE TROCAR AND WAS NEVER INSIDE THE PATIENT. PROCEDURE WAS EXTENDED BY ABOUT THIRTY MINUTES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18437915 ↗
• InjuryFeb 23, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ENDOTRACHEAL TUBE INSERTION ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE BROKE OFF WHILE USING TO SUTURE IN THE ENDOTRACHEAL TUBE. THE NEEDLE GOT EMBEDDED IN THE PATIENT¿S CHEEK. ALTHOUGH WE WERE ABLE TO REMOVE THE NEEDLE IT TOOK ABOUT AN HOUR TO FIND, AND THE PATIENT DID SUFFER ADDITIONAL TRAUMA AND ANESTHESIA WHILE LOCATING. THE PATIENT WAS UNDER ANESTHESIA FOR AN ADDITIONAL 45 MINUTES AND ALSO SUFFERED SOME ADDITIONAL TISSUE DAMAGE DURING THE TIME THE SURGEON WAS HAVING TO FIND/DIG OUT THE NEEDLE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16433360 ↗
• MalfunctionDec 29, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2022 AND SUTURE WAS USED. THE SUTURE BROKE WHEN THE SURGEON WAS USING IT TO CLOSE THE TISSUE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO FURTHER EVENT INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16069227 ↗
• MalfunctionDec 29, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2022 AND SUTURE WAS USED. THE SUTURE BROKE WHEN THE SURGEON WAS USING IT TO CLOSE THE TISSUE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO FURTHER EVENT INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16069223 ↗
• MalfunctionDec 29, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2022 AND SUTURE WAS USED. THE SUTURE BROKE WHEN THE SURGEON WAS USING IT TO CLOSE THE TISSUE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO FURTHER EVENT INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16069215 ↗
• MalfunctionDec 29, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2022 AND SUTURE WAS USED. THE SUTURE BROKE WHEN THE SURGEON WAS USING IT TO CLOSE THE TISSUE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO FURTHER EVENT INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16069214 ↗
• MalfunctionDec 29, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2022 AND SUTURE WAS USED. THE SUTURE BROKE WHEN THE SURGEON WAS USING IT TO CLOSE THE TISSUE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO FURTHER EVENT INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16069212 ↗
• MalfunctionAug 4, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GASTROJEJUNOSTOMY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, MULTIPLE SUTURE PACKAGES FROM THIS BOX-- THE NEEDLE POPPED OFF THE SUTURE WHILE THE SURGEON WAS USING THE DEVICE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15171835 ↗
• MalfunctionJun 23, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE. NEEDLE WAS RECOVERED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14787661 ↗
• MalfunctionFeb 25, 2022Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC PLACEMENT GPS STIMULATOR PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE FRAYED AND BROKE. ISSUE OCCURRED WITH FIVE OF THE SUTURES. 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 13607641 ↗
• MalfunctionFeb 25, 2022Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC PLACEMENT GPS STIMULATOR PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE FRAYED AND BROKE. ISSUE OCCURRED WITH FIVE OF THE SUTURES. 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 13607620 ↗
• MalfunctionFeb 25, 2022Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC PLACEMENT GPS STIMULATOR PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE FRAYED AND BROKE. ISSUE OCCURRED WITH FIVE OF THE SUTURES. 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 13607439 ↗
• MalfunctionFeb 25, 2022Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC PLACEMENT GPS STIMULATOR PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE FRAYED AND BROKE. ISSUE OCCURRED WITH FIVE OF THE SUTURES. 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 13607375 ↗
• MalfunctionFeb 25, 2022Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC PLACEMENT GPS STIMULATOR PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE FRAYED AND BROKE. ISSUE OCCURRED WITH FIVE OF THE SUTURES. 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 13607323 ↗
• MalfunctionDec 6, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GASTRIC BYPASS PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, TWO SUTURES HAD NEEDLES POP OFF. THEY WERE RETRIEVED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12937052 ↗

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-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.