PERMA-HAND C003DRecalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10705031023345), received between Mar 20, 2018 and Oct 16, 2025 — classified as 35 malfunctions.

The most frequently reported specific device problem is “Material Separation” (15 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 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 16, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, WHEN LOOKED AT THE PACKAGE BEFORE USE, IT WAS FOUND THAT THERE WAS A SMALL TRASH INSIDE THE PACKAGE. THE PACKAGE DID NOT OPEN. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. 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 23316185 ↗
• MalfunctionSep 5, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN SURGEON SUTURE WOUND, C003D WAS BROKEN EASIER. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20153132 ↗
• MalfunctionJul 24, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY A SALES REP THAT, CONTAMINATION BY FOREIGN MATTER OCCURRED. IT WAS A CONTROL RELEASE NEEDLE. NO PATIENT INVOLVEMENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19822750 ↗
• MalfunctionJul 24, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY A SALES REP THAT, CONTAMINATION BY FOREIGN MATTER OCCURRED. IT WAS A CONTROL RELEASE NEEDLE. NO PATIENT INVOLVEMENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19822749 ↗
• MalfunctionApr 25, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A BYPASS SURGERY OF STOMACH TO JEJUNUM ON (B)(6) 2024 AND SUTURE WAS USED. THE DOCTOR REMOVED THE TUMOR AT THE STOMACH, THEN THE PRODUCT WAS USED FOR INTERRUPTED SUTURING TO REINFORCE. WHEN SUTURING TO THE RESECTION PART, ONLY THE NEEDLE-TIP CAME OUT FROM THE TISSUE, SO THE DOCTOR GRASPED WITH FORCEPS AND PULLED OUT IT. AFTERWARDS, WHEN THE DOCTOR PASSED THE NEEDLE OF GRASPED WITH FORCEPS TO THE NURSE, IT WAS NOTICED THAT THE NEEDLE-TIP WAS BROKEN AND THEY LOOKED FOR THE NEEDLE, SO THEY FOUND OUT IT HAD FALLEN OUTSIDE THE ABDOMINAL CAVITY. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19180080 ↗
• MalfunctionAug 8, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE UNKNOWN PROCEDURE, THE NEEDLE WAS BROKEN. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17479514 ↗
• MalfunctionMar 30, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, C003D BROKE EASILY WHILE KNOTTING. CHANGED A NEW ONE AND COMPLETED THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16646457 ↗
• MalfunctionMar 30, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, C003D BROKE EASILY WHILE KNOTTING. CHANGED A NEW ONE AND COMPLETED THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16646283 ↗
• MalfunctionMar 30, 2023Break; Break

  IT WAS REPORTED, THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, C003D BROKE EASILY WHILE KNOTTING. CHANGED A NEW ONE AND COMPLETED THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16646280 ↗
• MalfunctionSep 22, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HARTMANN'S PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, A NEEDLE WAS FOUND IN THE OPERATIVE FIELD. AT THAT TIME, C003D HAD BEEN USED FOR SUTURE LIGATURE. IT IS UNKNOWN WHEN THE NEEDLE LEFT IN THE OPERATIVE FIELD FELL OUT, AND NEITHER THE DOCTOR NOR NURSE CONFIRMED THAT THE NEEDLE DROPPED OUT WHILE USING C003D. IT WAS ALSO UNKNOWN WHETHER THE NEEDLE LEFT IN THE OPERATIVE FIELD WAS C003D. THE NEEDLE THAT HAD DROPPED IN THE OPERATIVE FIELD WAS RETRIEVED, AND THE OPERATION WAS CONTINUED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12515549 ↗
• MalfunctionNov 2, 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 SUTURING. THE LOT NUMBER IS UNKNOWN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10773224 ↗
• MalfunctionMay 28, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED OFF THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10096166 ↗
• MalfunctionApr 23, 2020Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS OBSERVED TO BE TORN (FRAYED/CRIMPED). THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9991482 ↗
• MalfunctionApr 23, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED OFF THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9991075 ↗
• MalfunctionMar 2, 2020Material Separation; Material Separation

  IT WAS REPORTED THE PATIENT UNDERWENT AN UNKNOWN UROLOGICAL PROCEDURE ON (B)(6) 2020 AND THE SUTURE WAS USED. IT WAS REPORTED THAT WHEN OPENING THE PACKAGE, IT WAS FOUND THAT THE SUTURE HAD BEEN DETACHED FROM THE NEEDLE. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9774534 ↗
• MalfunctionMar 2, 2020Material Separation; Material Separation

  IT WAS REPORTED THE PATIENT UNDERWENT AN UNKNOWN UROLOGICAL PROCEDURE ON (B)(6) 2020 AND THE SUTURE WAS USED. IT WAS REPORTED THAT WHEN OPENING THE PACKAGE, IT WAS FOUND THAT THE SUTURE HAD BEEN DETACHED FROM THE NEEDLE. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9774521 ↗
• MalfunctionMar 2, 2020Material Separation; Material Separation

  IT WAS REPORTED THE PATIENT UNDERWENT AN UNKNOWN UROLOGICAL PROCEDURE ON (B)(6) 2020 AND THE SUTURE WAS USED. IT WAS REPORTED THAT WHEN OPENING THE PACKAGE, IT WAS FOUND THAT THE SUTURE HAD BEEN DETACHED FROM THE NEEDLE. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9774504 ↗
• MalfunctionMar 2, 2020Material Separation; Material Separation

  IT WAS REPORTED THE PATIENT UNDERWENT AN UNKNOWN UROLOGICAL PROCEDURE ON (B)(6) 2020 AND THE SUTURE WAS USED. IT WAS REPORTED THAT WHEN OPENING THE PACKAGE, IT WAS FOUND THAT THE SUTURE HAD BEEN DETACHED FROM THE NEEDLE. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9774490 ↗
• MalfunctionMar 2, 2020Material Separation; Material Separation

  IT WAS REPORTED THE PATIENT UNDERWENT AN UNKNOWN UROLOGICAL PROCEDURE ON (B)(6) 2020 AND THE SUTURE WAS USED. IT WAS REPORTED THAT WHEN OPENING THE PACKAGE, IT WAS FOUND THAT THE SUTURE HAD BEEN DETACHED FROM THE NEEDLE. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9774480 ↗
• MalfunctionMar 2, 2020Material Separation; Material Separation

  IT WAS REPORTED THE PATIENT UNDERWENT AN UNKNOWN UROLOGICAL PROCEDURE ON (B)(6) 2020 AND THE SUTURE WAS USED. IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN OPENING THE PACKAGE, IT WAS FOUND THAT THE SUTURE HAD BEEN DETACHED FROM THE NEEDLE. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9774466 ↗
• MalfunctionJan 13, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON UNKNOWN DATE AND THE SUTURE WAS USED. DURING PROCEDURE, IT WAS FOUND THAT THE SUTURE HAD BEEN DETACHED FROM THE NEEDLE. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9584518 ↗
• MalfunctionNov 7, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY IN 2019 AND THE SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE AND THREAD SEPARATION OCCURRED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9292119 ↗
• MalfunctionSep 19, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE SURGERY, IT WAS FOUND THAT THE NEEDLE HAD BEEN DETACHED FROM THE SUTURE. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9088590 ↗
• MalfunctionAug 8, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. BEFORE THE SURGERY, IT WAS FOUND THAT THERE HAD BEEN A FOREIGN SUBSTANCE LIKE A HAIR INSIDE THE PACKAGE BEFORE OPENING THE PACKAGE. THE PRODUCT WAS NOT USED FOR THE PATIENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8874231 ↗
• MalfunctionJul 3, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS FOUND THAT THERE HAD BEEN A PROBLEM WITH THE THICKNESS OF THE SUTURE AFTER THE PACKAGE WAS OPENED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8759072 ↗

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-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-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-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.