PERMA-HAND 685GRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10705031008229), received between Jul 9, 2018 and May 15, 2026 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY THE ACCOUNT CONTACT THAT DURING A LUXATING PATELLA SURGERY, EVERY TIME THE SURGEON WENT TO GO TIE THE KNOT WITH THE SUTURE, IT WAS BREAKING AND WON'T HOLD A KNOT. EVEN WITH EASY PRESSURE, THE SUTURE STILL BREAKS. DEVICES WILL BE RETURNING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25183968 ↗
• MalfunctionMay 15, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY THE ACCOUNT CONTACT THAT DURING A LUXATING PATELLA SURGERY, EVERY TIME THE SURGEON WENT TO GO TIE THE KNOT WITH THE SUTURE, IT WAS BREAKING AND WON'T HOLD A KNOT. EVEN WITH EASY PRESSURE, THE SUTURE STILL BREAKS. DEVICES WILL BE RETURNING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25183967 ↗
• MalfunctionApr 24, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. PRIOR TO USE ON THE PATIENT, DURING THE INSPECTION, STAFF REPORTED THE PRESENCE OF A HAIR INSIDE THE PRODUCT PACKAGING. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24981704 ↗
• MalfunctionApr 24, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. PRIOR TO USE ON THE PATIENT, DURING THE INSPECTION, STAFF REPORTED THE PRESENCE OF A HAIR INSIDE THE PRODUCT PACKAGING. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24981587 ↗
• MalfunctionApr 24, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. PRIOR TO USE ON THE PATIENT, DURING THE INSPECTION, STAFF REPORTED THE PRESENCE OF A HAIR INSIDE THE PRODUCT PACKAGING. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24981530 ↗
• InjuryDec 4, 2025Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE TO CONTROL POST-OP BLEEDING AFTER A CARDIAC CATHETERIZATION ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PROVIDER WAS CALLED TO SEE THE PATIENT POST-PROCEDURE DUE TO BLEEDING AT THE RIGHT SIDED ACCESS SITE. PRESSURE WAS APPLIED BY RN PRIOR TO PROVIDER COMING TO ROOM. WHEN THE PROVIDER ARRIVED, THE RN LEFT TO GET SUPPLIES REQUESTED BY PROVIDER, INCLUDING NEEDLE DRIVER, SUTURE, STERILE GLOVES, DRAPE, AND CHLORA-PREP STICK. WHEN PLACING NEW SUTURE AT THE SITE, THE SUTURE NEEDLE BROKE OFF WITHIN THE PATIENT'S SUBCUTANEOUS TISSUE WITH NO ENDS VISIBLE. THE PROVIDER ATTEMPTED TO PUSH THE NEEDLE THROUGH, HOWEVER WAS UNSUCCESSFUL. THE PROVIDER DECIDED TO TAKE THE PATIENT BACK TO THE LAB TO VISUALIZE THE SUTURE NEEDLE UNDER FLUOROSCOPY. THE PROVIDER WAS ABLE TO SUCCESSFULLY REMOVE THE SUTURE NEEDLE UNDER FLUOROSCOPY AND PLACED A NEW SUTURE WHILE IN THE LAB. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23716396 ↗
• MalfunctionAug 8, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST REDUCTION PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP, THAT DURING BREAST REDUCTION THE NEEDLE BROKE IN HALF. DEVICE IS AVAILABLE RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22748712 ↗
• MalfunctionMay 8, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE BREAKAGE DURING SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21988999 ↗
• MalfunctionSep 27, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE NEEDLE SNAPPED DURING SUTURING OF CHEST DRAIN SITE. ABLE TO RETRIEVE WITHOUT DIFFICULTY. NO HARM TO PATIENT- FAULTY EQUIPMENT. NEEDLE REMOVED. SUTURE NEEDLE SNAPPED AT CONNECTION TO THREAD DURING SUTURING. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20321878 ↗
• MalfunctionSep 25, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE MHRA HEALTH AUTHORITY: SUTURE NEEDLE SNAPPED DURING SUTURING OF CHEST DRAIN SITE. ABLE TO RETRIEVE WITHOUT DIFFICULTY. NO HARM TO PATIENT- FAULTY EQUIPMENT. NEEDLE REMOVED. SUTURE NEEDLE SNAPPED AT CONNECTION TO THREAD DURING SUTURING. DEVICE AVAILABILITY UNKNOWN. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20306467 ↗
• MalfunctionFeb 21, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT DURING A BREAST SURGERY THAT THE NEEDLE BROKE NEAR THE SWAGE. FRAGMENT WAS RECOVERED. X-RAY WAS ORDERED BUT THE FRAGMENT WAS FOUND BEFORE THEY ARRIVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. ONE DEVICE WILL BE RETURNED.. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18750756 ↗
• MalfunctionOct 27, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE TIP BROKE OFF. NO PATIENT INJURIES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18020157 ↗
• MalfunctionOct 26, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE TIP BROKE OFF. NO PATIENT INJURIES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18016367 ↗
• MalfunctionDec 2, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT PLACEMENT OF A PERMACATH ON SEPTEMBER 23, 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE SEPARATED FROM THE SUTURE. AN ADDITIONAL CUTDOWN OF 2.5 INCHES WAS REQUIRED TO RETRIEVE THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12916901 ↗
• MalfunctionApr 2, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CRANIOTOMY ON (B)(6)2019 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE TYING THE SUTURE TO A DRAIN WITH AN OUTER SKIN STITCH, THE TIP OF THE NEEDLE ON THE SUTURE BROKE OFF. THE NEEDLE TIP WAS RETRIEVED. AN ADDITIONAL 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 8473348 ↗
• MalfunctionApr 2, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CRANIOTOMY ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE TYING THE SUTURE TO A DRAIN WITH AN OUTER SKIN STITCH, THE TIP OF THE NEEDLE ON THE SUTURE BROKE OFF. THE NEEDLE TIP WAS RETRIEVED. AN ADDITIONAL 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 8473345 ↗
• MalfunctionJul 9, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED DURING A PROCEDURE ON (B)(6) 2018 A SUTURE WAS USED. WHILE PULLING THE SUTURE THROUGH THE TISSUE THE NEEDLE CAME OFF THE SUTURE AND FELL INTO THE PATIENT. AFTER 30 TO 45 MINUTES THE NEEDLE WAS RECOVERED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7671270 ↗

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.