STRATAFIX SXPP1A300Recalls & reported problems

Summary

The FDA's MAUDE database contains 113 adverse event reports that list this exact device (DI 10705031219359), received between Apr 10, 2018 and Apr 20, 2026 — classified as 10 injuries, 103 malfunctions.

The most frequently reported specific device problem is “Break” (78 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 113 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24926893 ↗
• MalfunctionFeb 19, 2026Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. THE SUTURE AND THE NEEDLE DETACHED. 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 ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24390744 ↗
• MalfunctionFeb 19, 2026Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. THE SUTURE AND THE NEEDLE DETACHED. 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 ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24390740 ↗
• MalfunctionJan 6, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING SURGERY, THE SWAGE PART OF THE NEEDLE WAS BROKEN. IT WAS NOT A CONTROL RELEASE NEEDLE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23976007 ↗
• MalfunctionDec 24, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE FIXATION TAB HAD BEEN BROKEN DURING USE, SO THE SUTURE COULD NOT CATCH AND DETACHED. 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 23888193 ↗
• MalfunctionNov 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE NEEDLE WAS DETACHED. 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 23650457 ↗
• MalfunctionAug 21, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS FOUND THAT THERE WAS A FOREIGN MATTER ON THE NEEDLE. (A BLACK FOREIGN MATTER ABOUT 2 MM). 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 22864671 ↗
• MalfunctionJun 30, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE AT THE PROXIMAL END. IT WAS NOT A CONTROL RELEASE NEEDLE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22359397 ↗
• MalfunctionApr 3, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HIP SURGERY ON (B)(6) 2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT A SMALL FRAGMENT/TIP OF A SUTURE NEEDLE WAS IDENTIFIED AS A FOREIGN IN THE WOUND AFTER A POSTOPERATIVE X-RAY. THE PATIENT HAD UNDERGONE SURGERY FOR A RT TOTAL HIP REPLACEMENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21766863 ↗
• InjuryJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT WOUND CLOSURE FOR VENTRAL MIDLINE CELIOTOMY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE PATIENT DEVELOPED SEVERE EDEMA, THE TISSUE TORE AND THE WOUND DEHISCENCE. AFTER DEHISCENCE, IT WAS ABDOMINAL CLOSURE WITH A DIFFERENT TYPE OF INTERRUPTED SUTURE. THERE WERE NO PROBLEMS WITH THE SUBSEQUENT PROCESS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Swelling/ Edema; Wound Dehiscence

  MAUDE report 19639996 ↗
• MalfunctionJun 25, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2024 AND BARBED SUTURE WAS USED. DURING AN UNKNOWN SURGERY, WHEN OPENED THE PACKAGE, IT WAS DIRT ON THE TIP OF THE NEEDLE, SO DID NOT USE. THE OPERATION TIME WAS NO EXTENSION. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19606804 ↗
• MalfunctionFeb 6, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2023 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, BEFORE USE, IT WAS NOTICED THAT THE FIXATION TAB WAS BROKEN. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. UPON EVALUATION OF THE RETURNED DEVICE, THE SIDES OF THE FIXATION TAB WERE FOUND TO BE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18655897 ↗
• MalfunctionDec 18, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS BROKEN DURING CONTINUOUS SUTURE. IT OCCURRED WHEN THE SURGEON SWITCHED THE NEEDLE TO A DIFFERENT HAND. THE BROKEN NEEDLE WAS COLLECTED IMMEDIATELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18344318 ↗
• MalfunctionOct 3, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, WHEN PUTTING THE 1ST STITCH, THE FIXATION TAB WAS BROKEN. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17865648 ↗
• MalfunctionSep 21, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY PROCEDURE ON (B)(6 2023 AND BARBED SUTURE WAS USED. THE FIXATION TAB WAS BROKEN DURING USE ON JOINT CAPSULE. THE DISLODGED FIXATION TAB REMAINED INTRAMUSCULARLY, BUT SINCE IT WAS AN ABSORBABLE MATERIAL, THE SURGEON DECIDED TO LEAVE IT IN PLACE, OPENED ANOTHER PRODUCT, AND COMPLETED THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17793373 ↗
• MalfunctionSep 19, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2023 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WITH USE ON THE FASCIA. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17776879 ↗
• MalfunctionSep 11, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON REALIZED THAT THE FIXATION TAB CAME OFF THE SUTURE DURING USE ON ABDOMINAL WALL FASCIA. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17726153 ↗
• InjuryAug 11, 2023Positioning Failure; Adverse Event Without Identified Device or Use Problem; Positioning Failure; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE PATIENT DEVELOPED AN ABDOMINAL WALL SCAR HERNIA. IN THE SURGEON'S OWN OPINION, THE SURGEON DID NOT RECOGNIZE IT AS A PRODUCT-RELATED COMPLICATION, BUT WHEN THE SALES REP CONFIRMED THE USAGE OF THE PRODUCT, THE SURGEON TOLD HIM THAT THERE WAS 15 CM OF SUTURE LEFT OVER AFTER SUTURING, COMPARED TO APPROXIMATELY 15-20 CM OF OPEN ABDOMINAL WOUND. THE SALES REP INFORMED THE SURGEON THAT THERE IS A RISK OF ISCHEMIA. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. IT WAS REPORTED THAT THE EVENT WAS MODERATE AND NON SERIOUS. [SURGEON¿S OPINION ABOUT CAUSAL RELATIONSHIP BETWEEN PRODUCT AND EVENT] NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Scar Tissue; Wound Dehiscence

  MAUDE report 17510363 ↗
• MalfunctionAug 10, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE FIXATION TAB CAME OFF THE SUTURE AT THE FIRST STITCH DURING WOUND CLOSURE. ANOTHER PRODUCT WAS USED BUT THE SAME THING HAPPENED. SUTURE METHOD WAS CONTINUOUS SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17498325 ↗
• MalfunctionAug 10, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE FIXATION TAB CAME OFF THE SUTURE AT THE FIRST STITCH DURING WOUND CLOSURE. ANOTHER PRODUCT WAS USED BUT THE SAME THING HAPPENED. SUTURE METHOD WAS CONTINUOUS SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17498323 ↗
• MalfunctionAug 9, 2023Material Integrity Problem; Material Integrity Problem

  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, BEFORE USE IT WAS FOUND THAT THE FIXATION TAB WAS ALREADY BROKEN. DURING THE VISUAL ASSESSMENT OF THE RETURNED NEEDLE SUTURE, THE SUTURE WAS EXAMINED, BODY FLUIDS AND DAMAGE AT SOME BARBS WERE NOTED AND BOTH SIDES OF THE FIXATION TAB WERE BROKEN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17486702 ↗
• MalfunctionJul 20, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN TOTAL HIP ARTHROPLASTY PROCEDURE ON (B)(6)2023 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE SURGEON PULLED THE SUTURE AT 2ND STITCH DURING CONTINUOUS SUTURE ON FASCIA, THE FIXATION TAB WAS BROKEN IN HALF. AFTER THAT, THE FIXATION TAB CAME OFF THE SUTURE. THIS HAPPENED IN 2 PRODUCTS IN A ROW AND SUTURE WAS COMPLETED WITH 3RD PRODUCT. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17361762 ↗
• MalfunctionJul 20, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN TOTAL HIP ARTHROPLASTY PROCEDURE ON (B)(6) 2023 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE SURGEON PULLED THE SUTURE AT 2ND STITCH DURING CONTINUOUS SUTURE ON FASCIA, THE FIXATION TAB WAS BROKEN IN HALF. AFTER THAT, THE FIXATION TAB CAME OFF THE SUTURE. THIS HAPPENED IN 2 PRODUCTS IN A ROW AND SUTURE WAS COMPLETED WITH 3RD PRODUCT. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17361761 ↗
• MalfunctionJun 30, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY A SALES REP THAT, IT WAS FOUND THAT THE FIXATION TAB WAS BROKEN. DURING THE VISUAL ASSESSMENT OF THE NEEDLE SUTURE, IT WAS NOTED THAT THE SWAGE AND ATTACHMENT AREA WAS AS EXPECTED. MARKS ON THE BODY NEEDLE THAT APPEARS TO BE BY A SURGICAL INSTRUMENT COULD BE OBSERVED. THE SUTURE WAS EXAMINED, BODY FLUIDS AND DAMAGE AT SOME BARBS WERE NOTED AND BOTH SIDES OF THE FIXATION TAB WERE BROKEN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17240275 ↗
• MalfunctionJun 22, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE FIXATION TAB WAS BROKEN WHEN STARTING SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17181247 ↗