PERMA-HAND C012DRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10705031023390), received between Jun 25, 2018 and Dec 3, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 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. A FOREIGN METAL OBJECT WAS FOUND IN THE PACKAGE. NO PATIENT CONSEQUENCES REPORTED WHEN THIS COMPLAINT EVENT OCCURRED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23706734 ↗
• MalfunctionMar 5, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2025, AND SUTURE WAS USED. WHEN OPEN THE PACKAGE, IT WAS FOUND THAT THERE WAS A BLACK DIRT ON THE TRAY. THE PRODUCT WAS NOT USED FOR THE PATIENT. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21529615 ↗
• MalfunctionJan 29, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE OFF FROM THE MAIN BODY OF THE NEEDLE. A FRAGMENT WAS CREATED BUT EASILY FOUND WITHIN THE PATIENT. NO X-RAYS OR ANY OTHER EXTRA INTERVENTION NEEDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO SURGICAL DELAY REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21263624 ↗
• MalfunctionMar 1, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING PROCEDURE, HAIR WAS FOUND INSIDE PACKAGING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18816259 ↗
• MalfunctionFeb 7, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT A PATIENT UNDERWENT A AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS FOUND THAT ONE SUTURE HAD BEEN MISSING. VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT ONE EMPTY OPEN OVERWRAP PACKET, ONE PAPER LID AND ONE WINDING FORMER WITH SEVEN NEEDLE-SUTURE COMBINATION, A SUTURE AND ONE DETACHED NEEDLE THAT PERTAIN TO PRODUCT CODE C012D. THIS PRODUCT CODE IS MULTISTRAND AND REQUIRED EIGHT NEEDLE-SUTURE PER PACKET. AFTER AN INVESTIGATION OF THE SUTURE, NO MISSING SUTURE WAS OBSERVED. HOWEVER, SHORT INSERTION WAS NOTED IN THE STRAND. THE VISUAL INSPECTION CONCLUDED THAT THE COMBINATION OF THE NEEDLE/SUTURE WAS DETACHED FROM THE NEEDLE SINCE THE INSERTION END OF THE SUTURE DID NOT MEET THE REQUIREMENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16314798 ↗
• MalfunctionAug 9, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN PACKAGE WAS OPENED, IT WAS FOUND THAT THE SUTURE HAD BEEN BROKEN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15195674 ↗
• MalfunctionAug 25, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLANNED PAROTIDECTOMY WITH FACIAL NERVE DISSECTION AND PRESERVATION IN (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, A NEEDLE TIP (1 MM) WAS NOTED TO HAVE BROKEN OFF. THE WOUND WAS EXPLORED WITHOUT SUCCESS, BUT RADIOGRAPH CONFIRMED PRESENCE. THE SURGEON DETERMINED THE RISK OUTWEIGHED THE BENEFIT OF REMOVAL. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12366510 ↗
• MalfunctionJun 30, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR PROCEDURE ON UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS DETACHED FROM THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8746870 ↗
• MalfunctionApr 4, 2019Material 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 SUTURE IS FALLING OFF BEFORE FINISHING SUTURING THE AREA. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8484625 ↗
• MalfunctionApr 4, 2019Material 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 SUTURE IS FALLING OFF BEFORE FINISHING SUTURING THE AREA. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8484576 ↗
• MalfunctionFeb 11, 2019Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AORTIC VALVE REPLACEMENT ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE-SUTURE WAS USED FOR LIFTING THE PERICARDIUM. AFTER SUTURING, IT WAS FOUND THAT THE NEEDLE TIP HAD BEEN BROKEN OFF. THE BROKEN PIECE OF NEEDLE TIP WAS FOUND WITH NO PROBLEM. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8327054 ↗
• MalfunctionJun 26, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOE AMPUTATION ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BREAKING IN THE MIDDLE OF THE STRAND WHILE TYING KNOTS. A SECOND LIKE SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7638356 ↗
• MalfunctionJun 25, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT PROCEDURE ON (B)(6) 2018 AND THE SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS DETACHED FROM THE SUTURE WHEN CLOSING THE CHEST. THE NEEDLE DID NOT FALL INTO THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7636615 ↗

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.