STRATAFIX SXPP1A301Recalls & reported problems

Summary

The FDA's MAUDE database contains 443 adverse event reports that list this exact device (DI 10705031227712), received between Nov 22, 2017 and Sep 23, 2026 — classified as 73 injuries, 370 malfunctions.

The most frequently reported specific device problem is “Break” (322 reports).

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 443 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Break

  It was reported that a patient underwent a Total Hip Arthroplasty: THA procedure on (b)(6) 2026 and barbed suture was used. During surgery, the suture was broken during passing through just before reverse stitching when using SYM during fascia closure. It was not a control release needle. Another product was used to complete the case. No adverse patient consequences were reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50866682 ↗
• MalfunctionSep 4, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50610441 ↗
• MalfunctionJun 23, 2026Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC SURGERY ON (B)(6) 2026 AND BARBED SUTURE WAS USED. THE NEEDLE WAS BROKEN AT THE 1ST STITCH WHEN THE PACKAGE WAS OPENED DURING SURGERY. IT WAS NOT 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25592905 ↗
• InjuryJun 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SIGMOID COLECTOMY PROCEDURE FOR SIGMOID COLON CANCER ON (B)(6) 2026 AND BARBED SUTURE WAS USED ON THE FASCIA. LEAKAGE OF EXUDATE AND GRANULATION TISSUE FORMATION WERE OBSERVED FROM THE NAVEL DURING THE OUTPATIENT VISIT IN (B)(6) 2026. THE DOCTOR DETERMINED IT WAS A CHRONIC WOUND INFECTION CAUSED BY THE SUTURES. GRANULATION TISSUE FORMATION AND WOUND INFECTION DUE TO FOREIGN BODY REACTION OF SUTURES. THE GRANULATION TISSUE THAT HAD GROWN OUTSIDE THE NAVEL WAS REMOVED AND COVERED WITH GAUZE BUT THE LEAKAGE OF EXUDATE FROM THE NAVEL CONTINUES. THE PATIENT IS CURRENTLY UNDERGOING FOLLOW-UP CARE AS AN OUTPATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fluid Discharge; Foreign Body Reaction; Granuloma; Unspecified Infection

  MAUDE report 25367703 ↗
• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT STOMA CLOSURE PROCEDURE ON (B)(6) 2026 AND A BARBED SUTURE WAS USED ON THE FASCIA. POST-OP, LEAKAGE OCCURRED AFTER STOMA CLOSURE AND REOPERATION WAS PERFORMED. THERE WAS ADHESION BETWEEN THE WOUND (PERITONEUM) AND THE INTESTINES AND UPON DISSECTION, THE FASCIAL SYMMETRY WAS ALSO FOUND TO BE ATTACHED TO THE INTESTINES. THE PATIENT'S OVERALL CONDITION WAS NOT GOOD, AND THE INTESTINES WERE WEAK. THE ADHESIONS BETWEEN THE INTESTINE AND SYMMETRY WERE NOT ALONG THE STAPLE LINES OF THE INTESTINE, BUT RATHER ON THE UNDAMAGED WALL OF THE INTESTINE. ADHESION OCCURRED FROM THE WOUND (PERITONEUM). NO SAMPLE WILL BE RETURNED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Adhesion(s); Fluid Discharge; Insufficient Information; Unspecified Tissue Injury

  MAUDE report 24966956 ↗
• MalfunctionMar 31, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING AN UNKNOWN ORTHOPEDIC SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY WHEN THE PRODUCT WAS USED. IT WAS NOT A CONTROL RELEASE NEEDLE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24742658 ↗
• MalfunctionMar 31, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN ORTHOPEDIC SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY AFTER THE PRODUCT WAS USED. IT WAS NOT A CONTROL RELEASE NEEDLE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24742176 ↗
• MalfunctionMar 20, 2026Positioning Failure; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A FASCIAL SUTURING IN ROBOT-ASSISTED LAPAROSCOPIC PROSTATECTOMY PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING SUTURING CHECK AFTER FASCIAL SUTURING IN ROBOT-ASSISTED LAPAROSCOPIC PROSTATECTOMY, THE SUTURE DETACHED. THEREFORE, STRATAFIX WAS REMOVED AND THE FASCIA WAS SUTURED WITH PDP. IT WAS NOT 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; Wound Dehiscence

  MAUDE report 24651294 ↗
• MalfunctionMar 12, 2026Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WERE USED. DURING SURGERY, THE SUTURE WAS BROKEN. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24582395 ↗
• InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT EMERGENCY LIFE-SAVING SURGERY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED ON THE FASCIA. THE PATIENT EXPERIENCED AN INFECTION. AS TREATMENT AFTER THE INFECTION, REOPERATION WAS PERFORMED. THERE ARE CURRENTLY NO PROBLEMS WITH THE PATIENT¿S CONDITION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 24379368 ↗
• MalfunctionDec 30, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, THE SUTURE WAS BROKEN DURING USE. IT WAS NOT 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 23927416 ↗
• MalfunctionDec 19, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN CHOLECYSTECTOMY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE SUTURE AND THE NEEDLE WERE DETACHED. THE PRODUCT WAS USED ON THE FASCIA. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23852692 ↗
• InjuryDec 4, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY (TKA) ON AN (B)(6) 2025 AND A BARBED SUTURE WAS USED ON THE FASCIA. FIVE DAYS AFTER SURGERY, WHEN THE PATIENT WAS CHANGED POSITION IN THE HOSPITAL ROOM, THE KNEE FELT UNCOMFORTABLE AND HAD IT EXAMINED, IT WAS FOUND THAT THE SUTURE WAS BROKEN AT THE WARD, SO RE-OPERATION WAS PERFORMED ON (B)(6) 2025. DURING THE REOPERATION, THE WOUND WAS INCISED AND THE FASCIA AND DERMIS WERE SUTURED AGAIN TO COMPLETE THE PROCEDURE. THE PATIENT'S CONDITION IS CURRENTLY STABLE AND PROGRESSING WITHOUT ANY PARTICULAR PROBLEMS. THE DOCTOR OPINES THAT THE CAUSE WAS NOT THE SUTURES, BUT THAT THE FASCIA WAS SUTURED IN EXTENSION RATHER THAN FLEXED. NO SAMPLE WILL BE RETURNED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 23717645 ↗
• InjuryDec 4, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY (TKA) ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED ON THE FASCIA. AFTER THE SURGERY, THE SUTURE WAS BROKEN AT THE WARD. THE SUTURE BREAKAGE OCCURRED 2 TO 3 DAYS AFTER SURGERY. IT WAS REPORTED THAT REOPERATION WAS REQUIRED, CAUSED BY AN INFECTION. UPON RE-OPERATION, WHEN MAKING AN INCISION IN THE WOUND, THE FASCIA WAS ALSO FOUND TO HAVE SEPARATED. DURING THE REOPERATION, THE WOUND WAS INCISED AND THE FASCIA AND DERMIS WERE SUTURED AGAIN TO COMPLETE THE PROCEDURE. THE PATIENT IS CURRENTLY UNDERGOING TREATMENT. THE DOCTOR OPINES THAT THE CAUSE IS NOT THE SUTURE ITSELF, BUT RATHER THE PROCEDURE ITSELF (BECAUSE THE KNEE WAS SUTURED IN AN EXTENDED POSITION, NOT IN A FLEXED POSITION). NO SAMPLE WILL BE RETURNED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 23717642 ↗
• MalfunctionNov 20, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, ONLY THE NEEDLE TIP WAS BROKEN DURING FASCIORRHAPHY. IT WAS NOT A CONTROL RELEASE NEEDLE. THE NEEDLE TIP FELL TO THE SURGICAL FIELD. THE FALLEN NEEDLE WAS SEARCHED USING X-RAYS, AND IT COULD BE REMOVED FROM INSIDE THE BODY. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23605745 ↗
• MalfunctionOct 30, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OB-GYN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. 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 23425599 ↗
• MalfunctionOct 27, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, WHEN USING STRATAFIX SYMMETRIC FOR WOUND CLOSURE, THE NEEDLE-SUTURE WAS DETACHED FROM THE JOINT PART AFTER THE 1ST TO 2ND STITCH. IT WAS HANDLED WITH OPENING AN ADDITIONAL PACKAGE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. 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 23395478 ↗
• MalfunctionOct 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING A TOTAL HIP ARTHROPLASTY: THA, THE PRODUCT INVOLVED WAS USED AS USUAL ON THE FASCIA, BUT THE NEEDLE DETACHED EVEN THOUGH THERE WAS NO TENSION APPLIED. THE PRODUCT WAS BEING USED NORMALLY, BUT THE NEEDLE CAME OFF EVEN THOUGH THERE WAS NO TENSION APPLIED. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. 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 23280195 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CHOLECYSTECTOMY ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE PATIENT WAS IN A VERY BAD CONDITION WHEN HE WAS TRANSPORTED, BUT SURGERY WAS PERFORMED IMMEDIATELY AT THE REQUEST OF HIS FAMILY. THE PRODUCT WAS USED ON THE FASCIA. THE PATIENT'S VITAL SIGN WAS BAD DURING THE SURGERY, AND THE OPERATION HAD TO BE COMPLETED QUICKLY. TWO BARBED SUTURES WERE USED TO CLOSE THE WOUND. THE MIDLINE INCISION ABOUT 15CM WAS STITCHED FROM THE UPPER AND LOWER ABDOMEN, THE MIDDLE PART WAS OVERLAPPED AND BACKSTITCH WAS PERFORMED. THE EPIDERMIS WAS CLOSED WITH A STAPLER. THE WOUND WAS DEHISCED AND THE ABDOMINAL CAVITY BECAME VISIBLE WHEN A STAPLER WAS REMOVED ON (B)(6). REOPERATION WAS PERFORMED AND THE FASCIA WAS SUTURED WITH NYLON SUTURE. THE PATIENT'S CURRENT CONDITION IS STABLE. THE WOUND WAS DEHISCED FROM THE UPPER TO LOWER ABDOMEN, AND THE SUTURE WAS STILL IN THE TISSUE. THE SUTURE WAS NOT BROKEN, BUT THAT THE TISSUES COULDN'T WITHSTAND. THE DOCTOR COMMENTED THAT THE CAUSE WAS NOT DUE TO THE SUTURE, BUT RATHER TO THE PATIENT'S CONDITION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22862326 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CHOLECYSTECTOMY ON (B)(6)2025 AND BARBED SUTURE WAS USED. THE PATIENT WAS IN A VERY BAD CONDITION WHEN HE WAS TRANSPORTED, BUT SURGERY WAS PERFORMED IMMEDIATELY AT THE REQUEST OF HIS FAMILY. THE PRODUCT WAS USED ON THE FASCIA. THE PATIENT'S VITAL SIGN WAS BAD DURING THE SURGERY, AND THE OPERATION HAD TO BE COMPLETED QUICKLY. TWO BARBED SUTURES WERE USED TO CLOSE THE WOUND. THE MIDLINE INCISION ABOUT 15CM WAS STITCHED FROM THE UPPER AND LOWER ABDOMEN, THE MIDDLE PART WAS OVERLAPPED AND BACKSTITCH WAS PERFORMED. THE EPIDERMIS WAS CLOSED WITH A STAPLER. THE WOUND WAS DEHISCED AND THE ABDOMINAL CAVITY BECAME VISIBLE WHEN A STAPLER WAS REMOVED ON AUGUST 4TH. RE OPERATION WAS PERFORMED AND THE FASCIA WAS SUTURED WITH NYLON SUTURE. THE PATIENT'S CURRENT CONDITION IS STABLE. THE WOUND WAS DEHISCED FROM THE UPPER TO LOWER ABDOMEN, AND THE SUTURE WAS STILL IN THE TISSUE. THE SUTURE WAS NOT BROKEN, BUT THAT THE TISSUES COULDN'T WITHSTAND. THE DOCTOR COMMENTED THAT THE CAUSE WAS NOT DUE TO THE SUTURE, BUT RATHER TO THE PATIENT'S CONDITION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22862315 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OVARIAN CANCER RESECTION ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED TO SIMULTANEOUSLY SUTURE THE FASCIA AND PERITONEUM. IT WAS STATED THAT THE TAB PLACEMENT METHOD AND SUTURING COMPLETION METHOD WERE PERFORMED PROPERLY. POST-OP, THE PATIENT EXPERIENCED AN INTESTINAL OBSTRUCTION AND AN ILEUS. A RE-OPERATION WAS PERFORMED. THERE WERE NO PROBLEMS WITH THE PATIENT'S SUBSEQUENT PROCESS AFTER SURGERY. THE PHYSICIANS OPINED THAT THE ANCHOR OF THE DEVICE MAY HAVE BEEN CAUGHT IN THE INTESTINE, CAUSING AN ILEUS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 22642758 ↗
• MalfunctionMay 13, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE ANCHOR WAS BROKEN WHEN TRIED TO USE IT DURING WOUND CLOSURE. (IT WAS FOUND THAT THERE HAD BEEN LIKE A KINK.) IT WAS NOT A CONTROL RELEASE NEEDLE. THIS EVENT WAS FOUND BEFORE USE. THE PRODUCT WAS USED ON THE FASCIA. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. PLEASE TAKE PHOTOS FOR JAPANESE CUSTOMER. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22013239 ↗
• InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT MIDLINE ABDOMINAL INCISION SURGERY ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE PATIENT HAD AN ABDOMINAL WALL SCAR HERNIA. THE DOCTOR THINKS THAT THE SUTURE WAS NOT BROKEN, BUT EITHER THE LEFT OR RIGHT SIDE WAS TORN BECAUSE THE STITCHES PROLAPSED THE SAME LENGTH AS THE INCISION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hernia

  MAUDE report 21972251 ↗
• MalfunctionMay 1, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ARTIFICIAL HEAD SURGERY ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN ARTIFICIAL HEAD SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE. THE PRODUCT WAS USED ON THE FASCIA. THERE WAS NO PROBLEM TO THE PATIENT. IT WAS NOT A CONTROL RELEASE NEEDLE. THIS EVENT WAS FOUND BEFORE USE. ANOTHER PACKAGE OF THE PRODUCT WAS USED TO COMPLETE THE CASE. 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 21944003 ↗
• MalfunctionApr 4, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE SUTURE WAS BROKEN DURING USE. IT WAS NOT 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. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21773318 ↗