STRATAFIX SXPP2B203Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10705031465169), received between Nov 4, 2022 and May 6, 2026 — classified as 2 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2026

  IT WAS A CASE OF RIGHT KNEE ARTHROPLASTY REVISION, DR. [REDACTED] WAS THE ONE WHO CLOSED THE FIRST AND SECOND LAYER OF THE SKIN AND LET HIS PA [PHYSICIAN ASSISTANT] CLOSED THE REST. WHILE CLOSING, THE PA NOTICED THAT THE TIP OF THE NEEDLE IS BROKEN. DR. [REDACTED] WAS NOTIFIED. X-RAY CALLED FOR BROKEN ITEM, CHARGE NURSE WAS NOTIFIED ALSO. X-RAY WAS DONE AND READ BY DR. [REDACTED] AND THE REPORT WAS POSITIVE FOR METALLIC FOREIGN BODY OVER THE MEDIAL ASPECT OF THE MEDIAL FEMORAL CONDYLE. DR. [REDACTED] OPEN THE SURGICAL SITE TO LOCATE THE BROKEN NEEDLE AND WHILE DOING IT HE IS USING THE SUCTION. SECOND X-RAY WAS DONE AND PER RADIOLOGY REPORT THE BROKEN NEEDLE HAS BEEN REMOVED. DR. [REDACTED] AND DR. [REDACTED] ALSO HAS A TELEPHONE CONVERSATION REGARDING THE RESULT.

  Patient problems: Foreign Body In Patient

  MAUDE report 25092677 ↗
• MalfunctionApr 6, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY (TKA) ON (B)(6) 2026 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT ORTHOPEDIC SURGEON, WAS USING BARBED SUTURE IN A TOTAL KNEE PROCEDURE. HE HAD TWO STRANDS BREAK ON HIM WHILE ATTEMPTING TO CLOSE THE WOUND. PROCEDURE WAS DELAYED BY 10 MINUTES. NO PATIENT HARM WAS REPORTED. DEVICES ARE AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24790038 ↗
• MalfunctionApr 6, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY (TKA) ON (B)(6) 2026 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT ORTHOPEDIC SURGEON, WAS USING BARBED SUTURE IN A TOTAL KNEE PROCEDURE. HE HAD TWO STRANDS BREAK ON HIM WHILE ATTEMPTING TO CLOSE THE WOUND. PROCEDURE WAS DELAYED BY 10 MINUTES. NO PATIENT HARM WAS REPORTED. DEVICES ARE AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24790036 ↗
• MalfunctionJun 13, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE SURGICAL FIRST ASSIST STATED THAT THE BARBS ON THE BARBED SUTURE DID NOT SEEM AS EFFECTIVE AS USUAL. NO PATIENT HARM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19534565 ↗
• MalfunctionJun 13, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE SURGICAL FIRST ASSIST STATED THAT THE BARBS ON THE BARBED SUTURE DID NOT SEEM AS EFFECTIVE AS USUAL. NO PATIENT HARM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19534564 ↗
• MalfunctionFeb 9, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL JOINT PROCEDURE IN 2024 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP REPORTED THAT 3 EACHES OF SXPP2B203 BROKE DURING A TOTAL JOINT CASE. ALL 3 SUTURES WERE SXPP2B203 LOT #TDBBZZ. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18676443 ↗
• MalfunctionFeb 9, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL JOINT PROCEDURE IN 2024 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP REPORTED THAT 3 EACHES OF SXPP2B203 BROKE DURING A TOTAL JOINT CASE. ALL 3 SUTURES WERE SXPP2B203 LOT #TDBBZZ. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18676440 ↗
• MalfunctionFeb 9, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL JOINT PROCEDURE IN 2024 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP REPORTED THAT 3 EACHES OF SXPP2B203 BROKE DURING A TOTAL JOINT CASE. ALL 3 SUTURES WERE SXPP2B203 LOT #TDBBZZ. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18676438 ↗
• MalfunctionOct 12, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL JOINT PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE THE NEEDLE WAS RANDOMLY POPPING OFF OF THE SWAGE. THE DOCTOR WAS NOT EXCESSIVELY PULLING OR MISHANDLING THE SUTURE. HE'S NOT BEING EXTREMELY MINDFUL OF HOW HE PULLS THE STITCH THROUGH TO PREVENT THIS FROM HAPPENING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17927139 ↗
• MalfunctionOct 12, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL JOINT PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE THE NEEDLE WAS RANDOMLY POPPING OFF OF THE SWAGE. THE DOCTOR WAS NOT EXCESSIVELY PULLING OR MISHANDLING THE SUTURE. HE'S NOT BEING EXTREMELY MINDFUL OF HOW HE PULLS THE STITCH THROUGH TO PREVENT THIS FROM HAPPENING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17926869 ↗
• MalfunctionOct 12, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL JOINT PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE THE NEEDLE WAS RANDOMLY POPPING OFF OF THE SWAGE. THE DOCTOR WAS NOT EXCESSIVELY PULLING OR MISHANDLING THE SUTURE. HE'S NOT BEING EXTREMELY MINDFUL OF HOW HE PULLS THE STITCH THROUGH TO PREVENT THIS FROM HAPPENING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17926538 ↗
• MalfunctionAug 9, 2023Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2023 AND BARBED SUTURE WAS USED. SUTURE BROKE IN THE MIDDLE AFTER THE VERY FIRST THROW. THERE WERE NO PATIENT CONSEQUENCES. DEVICE NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17494439 ↗
• MalfunctionAug 9, 2023Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2023 AND BARBED SUTURE WAS USED. SUTURE BROKE IN THE MIDDLE AFTER THE VERY FIRST THROW. THERE WERE NO PATIENT CONSEQUENCES. DEVICE NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17494432 ↗
• MalfunctionAug 9, 2023Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2023 AND BARBED SUTURE WAS USED. SUTURE BROKE IN THE MIDDLE AFTER THE VERY FIRST THROW. THERE WERE NO PATIENT CONSEQUENCES. DEVICE NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17494426 ↗
• MalfunctionMar 20, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, MULTIPLE #1 STRATAFIX SUTURES HAVE BEEN BREAKING IN THE CENTER OF THE SUTURE. IT IS DURING THE FIRST TWO TO THREE THROWS WHEN PULLING TO SET THE SUTURE. UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16579902 ↗
• MalfunctionMar 20, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, MULTIPLE #1 STRATAFIX SUTURES HAVE BEEN BREAKING IN THE CENTER OF THE SUTURE. IT IS DURING THE FIRST TWO TO THREE THROWS WHEN PULLING TO SET THE SUTURE. UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16579901 ↗
• MalfunctionMar 20, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, MULTIPLE #1 STRATAFIX SUTURES HAVE BEEN BREAKING IN THE CENTER OF THE SUTURE. IT IS DURING THE FIRST TWO TO THREE THROWS WHEN PULLING TO SET THE SUTURE. UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16579900 ↗
• MalfunctionMar 20, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, MULTIPLE #1 STRATAFIX SUTURES HAVE BEEN BREAKING IN THE CENTER OF THE SUTURE. IT IS DURING THE FIRST TWO TO THREE THROWS WHEN PULLING TO SET THE SUTURE. UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16579899 ↗
• MalfunctionMar 20, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, MULTIPLE #1 STRATAFIX SUTURES HAVE BEEN BREAKING IN THE CENTER OF THE SUTURE. IT IS DURING THE FIRST TWO TO THREE THROWS WHEN PULLING TO SET THE SUTURE. UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16579898 ↗
• MalfunctionFeb 7, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF THE SUTURE WHILE SUTURING CAPSULE CLOSED. IT WAS UNKNOWN IF HE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16310878 ↗
• MalfunctionFeb 7, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF THE SUTURE WHILE SUTURING CAPSULE CLOSED. IT WAS UNKNOWN IF HE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16310875 ↗
• MalfunctionFeb 7, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF THE SUTURE WHILE SUTURING CAPSULE CLOSED. IT WAS UNKNOWN IF HE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16310872 ↗
• MalfunctionFeb 7, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF THE SUTURE WHILE SUTURING CAPSULE CLOSED. IT WAS UNKNOWN IF HE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16310868 ↗
• MalfunctionFeb 7, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF THE SUTURE WHILE SUTURING CAPSULE CLOSED. IT WAS UNKNOWN IF HE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16310867 ↗
• MalfunctionFeb 7, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF THE SUTURE WHILE SUTURING CAPSULE CLOSED. IT WAS UNKNOWN IF HE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16310866 ↗