PERMA-HAND K834HRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10705031044418), received between Mar 28, 2018 and Aug 25, 2025 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Break” (18 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. 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED TO THE SALES REP THAT, THE NEEDLE BROKE IN TWO PIECES AND ABLE TO RETRIEVE BOTH OUT TO PATIENT. THERE WERE NO PATIENT ADVERSE EVENT. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22882598 ↗
• MalfunctionNov 2, 2021Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12738370 ↗
• MalfunctionOct 28, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PACEMAKER PROCEDURE ON AN UNKNOWN DATE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE IS BREAKING WHILE TYING DOWN THE PACEMAKER. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12713738 ↗
• MalfunctionOct 27, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE HAD BEEN DETACHED FROM THE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE.. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12708842 ↗
• MalfunctionJan 29, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BROKE WHEN TRYING TO PERFORM THE KNOTTING. THE SURGEON USED MORE THREADS THAN USUAL. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9643789 ↗
• MalfunctionNov 6, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE KEPT SNAPPING WHEN TYING OFF OR SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9285673 ↗
• MalfunctionNov 6, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE KEPT SNAPPING WHEN TYING OFF OR SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9285669 ↗
• MalfunctionNov 6, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE KEPT SNAPPING WHEN TYING OFF OR SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9285668 ↗
• MalfunctionNov 6, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE KEPT SNAPPING WHEN TYING OFF OR SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9285667 ↗
• MalfunctionNov 6, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE KEPT SNAPPING WHEN TYING OFF OR SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9285665 ↗
• MalfunctionNov 6, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE KEPT SNAPPING WHEN TYING OFF OR SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9285663 ↗
• MalfunctionNov 1, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BROKE WHEN TRYING TO PERFORM THE KNOTTING. THE SURGEON USED MORE THREADS THAN USUAL. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9268785 ↗
• MalfunctionNov 1, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BROKE WHEN TRYING TO PERFORM THE KNOTTING. THE SURGEON USED MORE THREADS THAN USUAL. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9268744 ↗
• MalfunctionNov 1, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BROKE WHEN TRYING TO PERFORM THE KNOTTING. THE SURGEON USED MORE THREADS THAN USUAL. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9268716 ↗
• MalfunctionNov 1, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BROKE WHEN TRYING TO PERFORM THE KNOTTING. THE SURGEON USED MORE THREADS THAN USUAL. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9268676 ↗
• MalfunctionMar 28, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NISSEN PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE THE SUTURE FRAYED AND BROKE WHILE BEING PULLED THROUGH THE TISSUE. PROCEDURE WAS COMPLETED WITH ANOTHER SUTURE OF THE SAME PRODUCT CODE FROM A DIFFERENT LOT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7380527 ↗
• MalfunctionMar 28, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NISSEN PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE THE SUTURE FRAYED AND BROKE WHILE BEING PULLED THROUGH THE TISSUE. PROCEDURE WAS COMPLETED WITH ANOTHER SUTURE OF THE SAME PRODUCT CODE FROM A DIFFERENT LOT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7380525 ↗
• MalfunctionMar 28, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NISSEN PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE THE SUTURE FRAYED AND BROKE WHILE BEING PULLED THROUGH THE TISSUE. PROCEDURE WAS COMPLETED WITH ANOTHER SUTURE OF THE SAME PRODUCT CODE FROM A DIFFERENT LOT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7380523 ↗
• MalfunctionMar 28, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NISSEN PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE THE SUTURE FRAYED AND BROKE WHILE BEING PULLED THROUGH THE TISSUE. PROCEDURE WAS COMPLETED WITH ANOTHER SUTURE OF THE SAME PRODUCT CODE FROM A DIFFERENT LOT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7380518 ↗

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.