ETHICON M660GRecalls & reported problems

Summary

The FDA's MAUDE database contains 102 adverse event reports that list this exact device (DI 10705031045521), received between Sep 15, 2023 and Aug 18, 2026 — classified as 102 malfunctions.

The most frequently reported specific device problem is “Material Separation” (88 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 102 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2026Delivered as Unsterile Product

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50298946 ↗
• MalfunctionAug 18, 2026Delivered as Unsterile Product

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50298943 ↗
• MalfunctionFeb 4, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PACEMAKER PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE AND WIRE ARE BROKEN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24260856 ↗
• MalfunctionNov 20, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT THE WIRES KEEP BREAKING UP. THERE WERE NO PATIENT ADVERSE EVENT. PRODUCT IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23606375 ↗
• MalfunctionNov 20, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT THE WIRES KEEP BREAKING UP. THERE WERE NO PATIENT ADVERSE EVENT. PRODUCT IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23606372 ↗
• MalfunctionOct 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLES ARE DETACHING FROM THE SUTURE. 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 23290034 ↗
• MalfunctionOct 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLES ARE DETACHING FROM THE SUTURE. 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 23289480 ↗
• MalfunctionOct 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PEDIATRIC PATIENT UNDERWENT A CARDIAC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, AFTER THE FIRST PASS THROUGH THE BABY'S STERNUM, THE NEEDLE DETACHED FROM THE WIRE, PREVENTING THE SURGEON FROM MAKING THE SECOND PASS TO CLOSE THE THORAX. AS A RESULT OF THE STEEL WIRE BREAKING, THE SURGEON HAD TO CLOSE THE BABY'S STERNUM WITH AN ABSORBABLE SUTURE INSTEAD OF A PERMANENT STEEL WIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. IT WAS OPINED BY THE SURGEON THAT IT IS PREFERABLE TO USE A STEEL WIRE FOR CLOSING A BABY¿S STERNUM, AS THE BABY WILL OFTEN NEED A SECOND SURGERY. THE STEEL WIRE PROVIDES PROTECTION WHEN REOPENING THE STERNUM FOR A SUBSEQUENT PROCEDURE. HOWEVER, WITH A STERNUM CLOSED WITH AN ABSORBABLE SUTURE, THE PATIENT DOES NOT BENEFIT FROM THIS PROTECTION, AND THERE IS A RISK THAT THE SAW COULD PENETRATE THE HEART DURING REOPERATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20506903 ↗
• MalfunctionOct 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PEDIATRIC PATIENT UNDERWENT A CARDIAC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, AFTER THE FIRST PASS THROUGH THE BABY'S STERNUM, THE NEEDLE DETACHED FROM THE WIRE, PREVENTING THE SURGEON FROM MAKING THE SECOND PASS TO CLOSE THE THORAX. AS A RESULT OF THE STEEL WIRE BREAKING, THE SURGEON HAD TO CLOSE THE BABY'S STERNUM WITH AN ABSORBABLE SUTURE INSTEAD OF A PERMANENT STEEL WIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. IT WAS OPINED BY THE SURGEON THAT IT IS PREFERABLE TO USE A STEEL WIRE FOR CLOSING A BABY¿S STERNUM, AS THE BABY WILL OFTEN NEED A SECOND SURGERY. THE STEEL WIRE PROVIDES PROTECTION WHEN REOPENING THE STERNUM FOR A SUBSEQUENT PROCEDURE. HOWEVER, WITH A STERNUM CLOSED WITH AN ABSORBABLE SUTURE, THE PATIENT DOES NOT BENEFIT FROM THIS PROTECTION, AND THERE IS A RISK THAT THE SAW COULD PENETRATE THE HEART DURING REOPERATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20506263 ↗
• MalfunctionOct 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PEDIATRIC PATIENT UNDERWENT A CARDIAC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, AFTER THE FIRST PASS THROUGH THE BABY'S STERNUM, THE NEEDLE DETACHED FROM THE WIRE, PREVENTING THE SURGEON FROM MAKING THE SECOND PASS TO CLOSE THE THORAX. AS A RESULT OF THE STEEL WIRE BREAKING, THE SURGEON HAD TO CLOSE THE BABY'S STERNUM WITH AN ABSORBABLE SUTURE INSTEAD OF A PERMANENT STEEL WIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. IT WAS OPINED BY THE SURGEON THAT IT IS PREFERABLE TO USE A STEEL WIRE FOR CLOSING A BABY¿S STERNUM, AS THE BABY WILL OFTEN NEED A SECOND SURGERY. THE STEEL WIRE PROVIDES PROTECTION WHEN REOPENING THE STERNUM FOR A SUBSEQUENT PROCEDURE. HOWEVER, WITH A STERNUM CLOSED WITH AN ABSORBABLE SUTURE, THE PATIENT DOES NOT BENEFIT FROM THIS PROTECTION, AND THERE IS A RISK THAT THE SAW COULD PENETRATE THE HEART DURING REOPERATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20506261 ↗
• MalfunctionOct 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PEDIATRIC PATIENT UNDERWENT A CARDIAC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, AFTER THE FIRST PASS THROUGH THE BABY'S STERNUM, THE NEEDLE DETACHED FROM THE WIRE, PREVENTING THE SURGEON FROM MAKING THE SECOND PASS TO CLOSE THE THORAX. AS A RESULT OF THE STEEL WIRE BREAKING, THE SURGEON HAD TO CLOSE THE BABY'S STERNUM WITH AN ABSORBABLE SUTURE INSTEAD OF A PERMANENT STEEL WIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. IT WAS OPINED BY THE SURGEON THAT IT IS PREFERABLE TO USE A STEEL WIRE FOR CLOSING A BABY¿S STERNUM, AS THE BABY WILL OFTEN NEED A SECOND SURGERY. THE STEEL WIRE PROVIDES PROTECTION WHEN REOPENING THE STERNUM FOR A SUBSEQUENT PROCEDURE. HOWEVER, WITH A STERNUM CLOSED WITH AN ABSORBABLE SUTURE, THE PATIENT DOES NOT BENEFIT FROM THIS PROTECTION, AND THERE IS A RISK THAT THE SAW COULD PENETRATE THE HEART DURING REOPERATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20506259 ↗
• MalfunctionOct 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PEDIATRIC PATIENT UNDERWENT A CARDIAC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, AFTER THE FIRST PASS THROUGH THE BABY'S STERNUM, THE NEEDLE DETACHED FROM THE WIRE, PREVENTING THE SURGEON FROM MAKING THE SECOND PASS TO CLOSE THE THORAX. AS A RESULT OF THE STEEL WIRE BREAKING, THE SURGEON HAD TO CLOSE THE BABY'S STERNUM WITH AN ABSORBABLE SUTURE INSTEAD OF A PERMANENT STEEL WIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. IT WAS OPINED BY THE SURGEON THAT IT IS PREFERABLE TO USE A STEEL WIRE FOR CLOSING A BABY¿S STERNUM, AS THE BABY WILL OFTEN NEED A SECOND SURGERY. THE STEEL WIRE PROVIDES PROTECTION WHEN REOPENING THE STERNUM FOR A SUBSEQUENT PROCEDURE. HOWEVER, WITH A STERNUM CLOSED WITH AN ABSORBABLE SUTURE, THE PATIENT DOES NOT BENEFIT FROM THIS PROTECTION, AND THERE IS A RISK THAT THE SAW COULD PENETRATE THE HEART DURING REOPERATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20506258 ↗
• MalfunctionOct 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PEDIATRIC PATIENT UNDERWENT A CARDIAC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, AFTER THE FIRST PASS THROUGH THE BABY'S STERNUM, THE NEEDLE DETACHED FROM THE WIRE, PREVENTING THE SURGEON FROM MAKING THE SECOND PASS TO CLOSE THE THORAX. AS A RESULT OF THE STEEL WIRE BREAKING, THE SURGEON HAD TO CLOSE THE BABY'S STERNUM WITH AN ABSORBABLE SUTURE INSTEAD OF A PERMANENT STEEL WIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. IT WAS OPINED BY THE SURGEON THAT IT IS PREFERABLE TO USE A STEEL WIRE FOR CLOSING A BABY¿S STERNUM, AS THE BABY WILL OFTEN NEED A SECOND SURGERY. THE STEEL WIRE PROVIDES PROTECTION WHEN REOPENING THE STERNUM FOR A SUBSEQUENT PROCEDURE. HOWEVER, WITH A STERNUM CLOSED WITH AN ABSORBABLE SUTURE, THE PATIENT DOES NOT BENEFIT FROM THIS PROTECTION, AND THERE IS A RISK THAT THE SAW COULD PENETRATE THE HEART DURING REOPERATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20506232 ↗
• MalfunctionOct 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PEDIATRIC PATIENT UNDERWENT A CARDIAC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, AFTER THE FIRST PASS THROUGH THE BABY'S STERNUM, THE NEEDLE DETACHED FROM THE WIRE, PREVENTING THE SURGEON FROM MAKING THE SECOND PASS TO CLOSE THE THORAX. AS A RESULT OF THE STEEL WIRE BREAKING, THE SURGEON HAD TO CLOSE THE BABY'S STERNUM WITH AN ABSORBABLE SUTURE INSTEAD OF A PERMANENT STEEL WIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. IT WAS OPINED BY THE SURGEON THAT IT IS PREFERABLE TO USE A STEEL WIRE FOR CLOSING A BABY¿S STERNUM, AS THE BABY WILL OFTEN NEED A SECOND SURGERY. THE STEEL WIRE PROVIDES PROTECTION WHEN REOPENING THE STERNUM FOR A SUBSEQUENT PROCEDURE. HOWEVER, WITH A STERNUM CLOSED WITH AN ABSORBABLE SUTURE, THE PATIENT DOES NOT BENEFIT FROM THIS PROTECTION, AND THERE IS A RISK THAT THE SAW COULD PENETRATE THE HEART DURING REOPERATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20506215 ↗
• MalfunctionOct 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PEDIATRIC PATIENT UNDERWENT A CARDIAC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, AFTER THE FIRST PASS THROUGH THE BABY'S STERNUM, THE NEEDLE DETACHED FROM THE WIRE, PREVENTING THE SURGEON FROM MAKING THE SECOND PASS TO CLOSE THE THORAX. AS A RESULT OF THE STEEL WIRE BREAKING, THE SURGEON HAD TO CLOSE THE BABY'S STERNUM WITH AN ABSORBABLE SUTURE INSTEAD OF A PERMANENT STEEL WIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. IT WAS OPINED BY THE SURGEON THAT IT IS PREFERABLE TO USE A STEEL WIRE FOR CLOSING A BABY¿S STERNUM, AS THE BABY WILL OFTEN NEED A SECOND SURGERY. THE STEEL WIRE PROVIDES PROTECTION WHEN REOPENING THE STERNUM FOR A SUBSEQUENT PROCEDURE. HOWEVER, WITH A STERNUM CLOSED WITH AN ABSORBABLE SUTURE, THE PATIENT DOES NOT BENEFIT FROM THIS PROTECTION, AND THERE IS A RISK THAT THE SAW COULD PENETRATE THE HEART DURING REOPERATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20506207 ↗
• MalfunctionOct 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PEDIATRIC PATIENT UNDERWENT A CARDIAC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, AFTER THE FIRST PASS THROUGH THE BABY'S STERNUM, THE NEEDLE DETACHED FROM THE WIRE, PREVENTING THE SURGEON FROM MAKING THE SECOND PASS TO CLOSE THE THORAX. AS A RESULT OF THE STEEL WIRE BREAKING, THE SURGEON HAD TO CLOSE THE BABY'S STERNUM WITH AN ABSORBABLE SUTURE INSTEAD OF A PERMANENT STEEL WIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. IT WAS OPINED BY THE SURGEON THAT IT IS PREFERABLE TO USE A STEEL WIRE FOR CLOSING A BABY¿S STERNUM, AS THE BABY WILL OFTEN NEED A SECOND SURGERY. THE STEEL WIRE PROVIDES PROTECTION WHEN REOPENING THE STERNUM FOR A SUBSEQUENT PROCEDURE. HOWEVER, WITH A STERNUM CLOSED WITH AN ABSORBABLE SUTURE, THE PATIENT DOES NOT BENEFIT FROM THIS PROTECTION, AND THERE IS A RISK THAT THE SAW COULD PENETRATE THE HEART DURING REOPERATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20506206 ↗
• MalfunctionOct 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PEDIATRIC PATIENT UNDERWENT A CARDIAC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, AFTER THE FIRST PASS THROUGH THE BABY'S STERNUM, THE NEEDLE DETACHED FROM THE WIRE, PREVENTING THE SURGEON FROM MAKING THE SECOND PASS TO CLOSE THE THORAX. AS A RESULT OF THE STEEL WIRE BREAKING, THE SURGEON HAD TO CLOSE THE BABY'S STERNUM WITH AN ABSORBABLE SUTURE INSTEAD OF A PERMANENT STEEL WIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. IT WAS OPINED BY THE SURGEON THAT IT IS PREFERABLE TO USE A STEEL WIRE FOR CLOSING A BABY¿S STERNUM, AS THE BABY WILL OFTEN NEED A SECOND SURGERY. THE STEEL WIRE PROVIDES PROTECTION WHEN REOPENING THE STERNUM FOR A SUBSEQUENT PROCEDURE. HOWEVER, WITH A STERNUM CLOSED WITH AN ABSORBABLE SUTURE, THE PATIENT DOES NOT BENEFIT FROM THIS PROTECTION, AND THERE IS A RISK THAT THE SAW COULD PENETRATE THE HEART DURING REOPERATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20506203 ↗
• MalfunctionOct 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PEDIATRIC PATIENT UNDERWENT A CARDIAC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, AFTER THE FIRST PASS THROUGH THE BABY'S STERNUM, THE NEEDLE DETACHED FROM THE WIRE, PREVENTING THE SURGEON FROM MAKING THE SECOND PASS TO CLOSE THE THORAX. AS A RESULT OF THE STEEL WIRE BREAKING, THE SURGEON HAD TO CLOSE THE BABY'S STERNUM WITH AN ABSORBABLE SUTURE INSTEAD OF A PERMANENT STEEL WIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. IT WAS OPINED BY THE SURGEON THAT IT IS PREFERABLE TO USE A STEEL WIRE FOR CLOSING A BABY¿S STERNUM, AS THE BABY WILL OFTEN NEED A SECOND SURGERY. THE STEEL WIRE PROVIDES PROTECTION WHEN REOPENING THE STERNUM FOR A SUBSEQUENT PROCEDURE. HOWEVER, WITH A STERNUM CLOSED WITH AN ABSORBABLE SUTURE, THE PATIENT DOES NOT BENEFIT FROM THIS PROTECTION, AND THERE IS A RISK THAT THE SAW COULD PENETRATE THE HEART DURING REOPERATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20506200 ↗
• MalfunctionOct 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PEDIATRIC PATIENT UNDERWENT A CARDIAC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, AFTER THE FIRST PASS THROUGH THE BABY'S STERNUM, THE NEEDLE DETACHED FROM THE WIRE, PREVENTING THE SURGEON FROM MAKING THE SECOND PASS TO CLOSE THE THORAX. AS A RESULT OF THE STEEL WIRE BREAKING, THE SURGEON HAD TO CLOSE THE BABY'S STERNUM WITH AN ABSORBABLE SUTURE INSTEAD OF A PERMANENT STEEL WIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. IT WAS OPINED BY THE SURGEON THAT IT IS PREFERABLE TO USE A STEEL WIRE FOR CLOSING A BABY¿S STERNUM, AS THE BABY WILL OFTEN NEED A SECOND SURGERY. THE STEEL WIRE PROVIDES PROTECTION WHEN REOPENING THE STERNUM FOR A SUBSEQUENT PROCEDURE. HOWEVER, WITH A STERNUM CLOSED WITH AN ABSORBABLE SUTURE, THE PATIENT DOES NOT BENEFIT FROM THIS PROTECTION, AND THERE IS A RISK THAT THE SAW COULD PENETRATE THE HEART DURING REOPERATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20506184 ↗
• MalfunctionOct 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PEDIATRIC PATIENT UNDERWENT A CARDIAC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, AFTER THE FIRST PASS THROUGH THE BABY'S STERNUM, THE NEEDLE DETACHED FROM THE WIRE, PREVENTING THE SURGEON FROM MAKING THE SECOND PASS TO CLOSE THE THORAX. AS A RESULT OF THE STEEL WIRE BREAKING, THE SURGEON HAD TO CLOSE THE BABY'S STERNUM WITH AN ABSORBABLE SUTURE INSTEAD OF A PERMANENT STEEL WIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. IT WAS OPINED BY THE SURGEON THAT IT IS PREFERABLE TO USE A STEEL WIRE FOR CLOSING A BABY¿S STERNUM, AS THE BABY WILL OFTEN NEED A SECOND SURGERY. THE STEEL WIRE PROVIDES PROTECTION WHEN REOPENING THE STERNUM FOR A SUBSEQUENT PROCEDURE. HOWEVER, WITH A STERNUM CLOSED WITH AN ABSORBABLE SUTURE, THE PATIENT DOES NOT BENEFIT FROM THIS PROTECTION, AND THERE IS A RISK THAT THE SAW COULD PENETRATE THE HEART DURING REOPERATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20506181 ↗
• MalfunctionOct 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PEDIATRIC PATIENT UNDERWENT A CARDIAC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, AFTER THE FIRST PASS THROUGH THE BABY'S STERNUM, THE NEEDLE DETACHED FROM THE WIRE, PREVENTING THE SURGEON FROM MAKING THE SECOND PASS TO CLOSE THE THORAX. AS A RESULT OF THE STEEL WIRE BREAKING, THE SURGEON HAD TO CLOSE THE BABY'S STERNUM WITH AN ABSORBABLE SUTURE INSTEAD OF A PERMANENT STEEL WIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. IT WAS OPINED BY THE SURGEON THAT IT IS PREFERABLE TO USE A STEEL WIRE FOR CLOSING A BABY¿S STERNUM, AS THE BABY WILL OFTEN NEED A SECOND SURGERY. THE STEEL WIRE PROVIDES PROTECTION WHEN REOPENING THE STERNUM FOR A SUBSEQUENT PROCEDURE. HOWEVER, WITH A STERNUM CLOSED WITH AN ABSORBABLE SUTURE, THE PATIENT DOES NOT BENEFIT FROM THIS PROTECTION, AND THERE IS A RISK THAT THE SAW COULD PENETRATE THE HEART DURING REOPERATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20506180 ↗
• MalfunctionOct 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PEDIATRIC PATIENT UNDERWENT A CARDIAC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, AFTER THE FIRST PASS THROUGH THE BABY'S STERNUM, THE NEEDLE DETACHED FROM THE WIRE, PREVENTING THE SURGEON FROM MAKING THE SECOND PASS TO CLOSE THE THORAX. AS A RESULT OF THE STEEL WIRE BREAKING, THE SURGEON HAD TO CLOSE THE BABY'S STERNUM WITH AN ABSORBABLE SUTURE INSTEAD OF A PERMANENT STEEL WIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. IT WAS OPINED BY THE SURGEON THAT IT IS PREFERABLE TO USE A STEEL WIRE FOR CLOSING A BABY¿S STERNUM, AS THE BABY WILL OFTEN NEED A SECOND SURGERY. THE STEEL WIRE PROVIDES PROTECTION WHEN REOPENING THE STERNUM FOR A SUBSEQUENT PROCEDURE. HOWEVER, WITH A STERNUM CLOSED WITH AN ABSORBABLE SUTURE, THE PATIENT DOES NOT BENEFIT FROM THIS PROTECTION, AND THERE IS A RISK THAT THE SAW COULD PENETRATE THE HEART DURING REOPERATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20506162 ↗
• MalfunctionOct 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PEDIATRIC PATIENT UNDERWENT A CARDIAC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, AFTER THE FIRST PASS THROUGH THE BABY'S STERNUM, THE NEEDLE DETACHED FROM THE WIRE, PREVENTING THE SURGEON FROM MAKING THE SECOND PASS TO CLOSE THE THORAX. AS A RESULT OF THE STEEL WIRE BREAKING, THE SURGEON HAD TO CLOSE THE BABY'S STERNUM WITH AN ABSORBABLE SUTURE INSTEAD OF A PERMANENT STEEL WIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. IT WAS OPINED BY THE SURGEON THAT IT IS PREFERABLE TO USE A STEEL WIRE FOR CLOSING A BABY¿S STERNUM, AS THE BABY WILL OFTEN NEED A SECOND SURGERY. THE STEEL WIRE PROVIDES PROTECTION WHEN REOPENING THE STERNUM FOR A SUBSEQUENT PROCEDURE. HOWEVER, WITH A STERNUM CLOSED WITH AN ABSORBABLE SUTURE, THE PATIENT DOES NOT BENEFIT FROM THIS PROTECTION, AND THERE IS A RISK THAT THE SAW COULD PENETRATE THE HEART DURING REOPERATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20506156 ↗
• MalfunctionOct 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PEDIATRIC PATIENT UNDERWENT A CARDIAC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, AFTER THE FIRST PASS THROUGH THE BABY'S STERNUM, THE NEEDLE DETACHED FROM THE WIRE, PREVENTING THE SURGEON FROM MAKING THE SECOND PASS TO CLOSE THE THORAX. AS A RESULT OF THE STEEL WIRE BREAKING, THE SURGEON HAD TO CLOSE THE BABY'S STERNUM WITH AN ABSORBABLE SUTURE INSTEAD OF A PERMANENT STEEL WIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. IT WAS OPINED BY THE SURGEON THAT IT IS PREFERABLE TO USE A STEEL WIRE FOR CLOSING A BABY¿S STERNUM, AS THE BABY WILL OFTEN NEED A SECOND SURGERY. THE STEEL WIRE PROVIDES PROTECTION WHEN REOPENING THE STERNUM FOR A SUBSEQUENT PROCEDURE. HOWEVER, WITH A STERNUM CLOSED WITH AN ABSORBABLE SUTURE, THE PATIENT DOES NOT BENEFIT FROM THIS PROTECTION, AND THERE IS A RISK THAT THE SAW COULD PENETRATE THE HEART DURING REOPERATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20506155 ↗
• MalfunctionOct 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PEDIATRIC PATIENT UNDERWENT A CARDIAC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, AFTER THE FIRST PASS THROUGH THE BABY'S STERNUM, THE NEEDLE DETACHED FROM THE WIRE, PREVENTING THE SURGEON FROM MAKING THE SECOND PASS TO CLOSE THE THORAX. AS A RESULT OF THE STEEL WIRE BREAKING, THE SURGEON HAD TO CLOSE THE BABY'S STERNUM WITH AN ABSORBABLE SUTURE INSTEAD OF A PERMANENT STEEL WIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. IT WAS OPINED BY THE SURGEON THAT IT IS PREFERABLE TO USE A STEEL WIRE FOR CLOSING A BABY¿S STERNUM, AS THE BABY WILL OFTEN NEED A SECOND SURGERY. THE STEEL WIRE PROVIDES PROTECTION WHEN REOPENING THE STERNUM FOR A SUBSEQUENT PROCEDURE. HOWEVER, WITH A STERNUM CLOSED WITH AN ABSORBABLE SUTURE, THE PATIENT DOES NOT BENEFIT FROM THIS PROTECTION, AND THERE IS A RISK THAT THE SAW COULD PENETRATE THE HEART DURING REOPERATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20506141 ↗

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.