ETHICON 1916GRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10705031002920), received between Jan 12, 2018 and May 21, 2020 — classified as 2 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SCAR REVISION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURES WERE SNAPPING. IT WAS REPORTED THAT THE DOCTOR OPENED NEW SUTURES TO COMPLETE CASE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10080347 ↗
• MalfunctionMay 21, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SCAR REVISION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURES WERE SNAPPING. IT WAS REPORTED THAT THE DOCTOR OPENED NEW SUTURES TO COMPLETE CASE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10080334 ↗
• MalfunctionMay 21, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SCAR REVISION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURES WERE SNAPPING. IT WAS REPORTED THAT THE DOCTOR OPENED NEW SUTURES TO COMPLETE CASE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10080331 ↗
• MalfunctionMay 21, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SCAR REVISION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURES WERE SNAPPING. IT WAS REPORTED THAT THE DOCTOR OPENED NEW SUTURES TO COMPLETE CASE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10080330 ↗
• MalfunctionMay 21, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SCAR REVISION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURES WERE SNAPPING. IT WAS REPORTED THAT THE DOCTOR OPENED NEW SUTURES TO COMPLETE CASE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10080328 ↗
• MalfunctionMay 21, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SCAR REVISION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURES WERE SNAPPING. IT WAS REPORTED THAT THE DOCTOR OPENED NEW SUTURES TO COMPLETE CASE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10080326 ↗
• MalfunctionNov 15, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE IT WAS REPORTED THAT THE SUTURE WAS EASILY BROKEN. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9332139 ↗
• MalfunctionNov 15, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE IT WAS REPORTED THAT THE SUTURE WAS EASILY BROKEN. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9332093 ↗
• MalfunctionApr 18, 2019Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED DURING AN UNKNOWN PROCEDURE THE CUSTOMER NOTICED THE SUTURE PACKET WAS UNSEALED, AFFECTING THE STERILITY OF THE PACKET. AN ADDITIONAL PACKET WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8529163 ↗
• MalfunctionApr 18, 2019Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED DURING AN UNKNOWN PROCEDURE THE CUSTOMER NOTICED THE SUTURE PACKET WAS UNSEALED, AFFECTING THE STERILITY OF THE PACKET. AN ADDITIONAL PACKET WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8529095 ↗
• MalfunctionApr 9, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SURGEON WENT TO USE THE SUTURE AND THE NEEDLE BROKE AWAY FROM THE SUTURE. ANOTHER SUTURE WAS SOURCED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8497155 ↗
• MalfunctionApr 9, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SURGEON WENT TO USE THE SUTURE AND THE NEEDLE BROKE AWAY FROM THE SUTURE. ANOTHER SUTURE WAS SOURCED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8497154 ↗
• MalfunctionApr 9, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SURGEON WENT TO USE THE SUTURE AND THE NEEDLE BROKE AWAY FROM THE SUTURE. ANOTHER SUTURE WAS SOURCED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8497153 ↗
• MalfunctionFeb 12, 2019Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RHINOPLASTY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE OFF THE NEEDLE. THE SUTURE TORE WHILE THE SURGEON WAS TYING IT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8332431 ↗
• MalfunctionFeb 12, 2019Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RHINOPLASTY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE OFF THE NEEDLE. THE SUTURE TORE WHILE THE SURGEON WAS TYING IT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8332430 ↗
• InjuryJun 5, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT CLEFT PALATE PROCEDURE ON UNKNOWN DATE AND SUTURE WAS USED. THREE DAYS POST OPERATION THE WOUND OF THE PATIENT RUPTURED ALONG THE INCISION LINE. AN ADDITIONAL PROCEDURE WAS PERFORMED TO RE-SUTURE THE WOUND. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Not Applicable; Wound Dehiscence

  MAUDE report 7569653 ↗
• InjuryJun 5, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT CLEFT PALATE PROCEDURE ON UNKNOWN DATE AND SUTURE WAS USED. THREE DAYS POST OPERATION THE WOUND OF THE PATIENT RUPTURED ALONG THE INCISION LINE. AN ADDITIONAL PROCEDURE WAS PERFORMED TO RE-SUTURE THE WOUND. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Not Applicable; Wound Dehiscence

  MAUDE report 7569601 ↗
• MalfunctionApr 23, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT PATIENT UNDERWENT AN ARTHROPLASTY PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. THE NEEDLE POPPED OFF THE SUTURE AT THE SWAGE AS THE SUTURE WAS PASSING THROUGH TISSUE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7451296 ↗
• MalfunctionApr 23, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT PATIENT UNDERWENT AN ARTHROPLASTY PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. THE NEEDLE POPPED OFF THE SUTURE AT THE SWAGE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7451244 ↗
• MalfunctionApr 23, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT PATIENT UNDERWENT AN ARTHROPLASTY PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. THE NEEDLE POPPED OFF THE SUTURE AT THE SWAGE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7451209 ↗
• MalfunctionJan 12, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A BLEPHOPLASTY PROCEDURE AND SUTURE WAS USED. IT WAS REPORTED THAT THE STITCHES OPENED POST OPERATIVELY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7185771 ↗

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.