STRATAFIX SXPP1A445Recalls & reported problems

Summary

The FDA's MAUDE database contains 143 adverse event reports that list this exact device (DI 10705031245273), received between Dec 11, 2018 and Apr 29, 2026 — classified as 59 injuries, 84 malfunctions.

The most frequently reported specific device problem is “Break” (90 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 143 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL THAT, THEY HAD A STRATAFIX SUTURE SXPP1A445 OPENED TO STERILE FIELD, UPON OPENING THE INNER PACKAGING, THERE WAS A FINE HAIR WRAPPED AROUND INSIDE THE CASE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE DEVICE WAS RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25035384 ↗
• InjuryMar 30, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE PATIENT REPRESENTED TO EMERGENCY AT ABOUT POST-OP 1 WEEK WITH FACIAL DEHISCENCE AND BOWEL EVISCERATION. ON TAKE BACK, THE FLAT, RECTANGULAR ANCHORING TAB HAD BROKEN OFF AND WAS FOUND IN THE SUBCUTANEOUS TISSUE. THE REMAINING SUTURE WAS UNRAVELLED AND ANCHORED TO THE FACIA ON THE OPPOSITE SIDE. FORTUNATELY, ABDOMEN WAS SUCCESSFULLY CLOSED A SECOND TIME AND THE PATIENT IS RECOVERING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information; Wound Dehiscence

  MAUDE report 24709232 ↗
• MalfunctionFeb 25, 2026Material Frayed

  IT WAS REPORTED A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE PHYSICIAN ASSISTANT MADE THREE TO FOUR PASSES WITH THE SUTURE FOR THE FIRST LAYER. ON THE SUBSEQUENT PASS THE SUTURE SPLIT/FRAYED AT THE JUNCTION WHERE THE NEEDLE CONNECTS TO THE SUTURE APPEARING TO SEPARATE AT THE NEEDLE SUTURE INTERFACE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24445642 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE FOR A POLY SWAB ON A TOTAL KNEE ARTHROPLASTY ON (B)(6) 2025 AND A BARBED SUTURE WAS USED. POST-OP, DURING PHYSICAL THERAPY, THE PATIENT FELT A PAIN IN THE KNEE ON (B)(6) 2025. THE PATIENT WENT TO SEE THE SURGEON AND PA AND A PALPABLE DEFECT COULD BE FELT AND THE KNEE HAD A SMALL DEFECT. THE PATIENT WAS LOCKED IN A FIXED POSITION AND IS DOING GOOD. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pain; Wound Dehiscence

  MAUDE report 24390179 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE FOR A POLY SWAB ON A TOTAL KNEE ARTHROPLASTY ON (B)(6) 2025 AND A BARBED SUTURE WAS USED. POST-OP, DURING PHYSICAL THERAPY, THE PATIENT FELT A PAIN IN THE KNEE ON (B)(6) 2025. THE PATIENT WENT TO SEE THE SURGEON AND PA AND A PALPABLE DEFECT COULD BE FELT AND THE KNEE HAD A SMALL DEFECT. THE PATIENT WAS LOCKED IN A FIXED POSITION AND IS DOING GOOD. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pain; Wound Dehiscence

  MAUDE report 24390176 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT FELL AND HIT HER KNEE. THE SURGEON AND PA COULDN¿T FEEL A PALPABLE DEFECT. THE PATIENT WAS TAKEN TO SPORTS MED AND AN ULTRASOUND WAS USED. A SMALL DEFECTED WAS NOTICED ON (B)(6) 2025. THE SURGEON SAW THE PATIENT ON (B)(6) 2025 AND THE PATIENT WAS PUT IN A KNEE IMMOBILIZER. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information; Wound Dehiscence

  MAUDE report 24390174 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT FELL AND HIT HER KNEE. THE SURGEON AND PA COULDN¿T FEEL A PALPABLE DEFECT. THE PATIENT WAS TAKEN TO SPORTS MED AND AN ULTRASOUND WAS USED. A SMALL DEFECTED WAS NOTICED ON (B)(6) 2025. THE SURGEON SAW THE PATIENT ON (B)(6) 2025 AND THE PATIENT WAS PUT IN A KNEE IMMOBILIZER. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information; Wound Dehiscence

  MAUDE report 24390172 ↗
• MalfunctionFeb 18, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BROKE AFTER REVERSE STITCH BEFORE SUTURING WAS COMPLETED. IT BROKE ABOUT 5CM AWAY FROM THE SWAGE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THERE WAS NO SIGNIFICANT DELAY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24377605 ↗
• InjuryJan 29, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. APPROXIMATELY 4 WEEKS POST-OP, THE PATIENT EXPERIENCED AN ARTHROTOMY RUPTURE. IT WAS REPORTED TO SALES REP BY THE SURGEON THAT HE IS AN EXPERIENCED USER OF THE BARBED SUTURE FOR OVER 5 YEARS AND THOUSANDS OF CASES WITH NO ISSUES. THE SURGEON HAS HAD SOME ISSUES WITH THE BARBED SUTURE OVER THE PAST COUPLE MONTHS. IT WAS REPORTED THAT THE SURGEON RECENTLY CHANGED HIS TECHNIQUE AND CLOSED THE KNEE IN MAXIMUM EXTENSION. THEY DISCUSSED THE EMPHASIS IN PUTTING IN THE KNEE INTO FLEXION. IT WAS REPORTED THAT THE SURGEON TESTS THE KNEE THROUGH RANGE OF MOTION SO IT SHOULDN'T BE AN ISSUE. THE LOSS OF BSR OVER THE WEEKS WAS DISCUSSED AND THOUGH IT MAY BE STRONG ENOUGH TO HOLD FOR THE INITIAL RANGE OF MOTION TEST, IT MAY NOT ONCE THE BSR STARTS TO DEGRADE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Swelling/ Edema; Wound Dehiscence

  MAUDE report 24216010 ↗
• InjuryJan 29, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. APPROXIMATELY 4 WEEKS POST-OP, THE PATIENT EXPERIENCED AN ARTHROTOMY RUPTURE. IT WAS REPORTED TO SALES REP BY THE SURGEON THAT HE IS AN EXPERIENCED USER OF THE BARBED SUTURE FOR OVER 5 YEARS AND THOUSANDS OF CASES WITH NO ISSUES. THE SURGEON HAS HAD SOME ISSUES WITH THE BARBED SUTURE OVER THE PAST COUPLE MONTHS. IT WAS REPORTED THAT THE SURGEON RECENTLY CHANGED HIS TECHNIQUE AND CLOSED THE KNEE IN MAXIMUM EXTENSION. THEY DISCUSSED THE EMPHASIS IN PUTTING IN THE KNEE INTO FLEXION. IT WAS REPORTED THAT THE SURGEON TESTS THE KNEE THROUGH RANGE OF MOTION SO IT SHOULDN'T BE AN ISSUE. THE LOSS OF BSR OVER THE WEEKS WAS DISCUSSED AND THOUGH IT MAY BE STRONG ENOUGH TO HOLD FOR THE INITIAL RANGE OF MOTION TEST, IT MAY NOT ONCE THE BSR STARTS TO DEGRADE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Swelling/ Edema; Wound Dehiscence

  MAUDE report 24215983 ↗
• InjuryJan 29, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. APPROXIMATELY 4 WEEKS POST-OP, THE PATIENT EXPERIENCED AN ARTHROTOMY RUPTURE. IT WAS REPORTED TO SALES REP BY THE SURGEON THAT HE IS AN EXPERIENCED USER OF THE BARBED SUTURE FOR OVER 5 YEARS AND THOUSANDS OF CASES WITH NO ISSUES. THE SURGEON HAS HAD SOME ISSUES WITH THE BARBED SUTURE OVER THE PAST COUPLE MONTHS. IT WAS REPORTED THAT THE SURGEON RECENTLY CHANGED HIS TECHNIQUE AND CLOSED THE KNEE IN MAXIMUM EXTENSION. THEY DISCUSSED THE EMPHASIS IN PUTTING IN THE KNEE INTO FLEXION. IT WAS REPORTED THAT THE SURGEON TESTS THE KNEE THROUGH RANGE OF MOTION SO IT SHOULDN'T BE AN ISSUE. THE LOSS OF BSR OVER THE WEEKS WAS DISCUSSED AND THOUGH IT MAY BE STRONG ENOUGH TO HOLD FOR THE INITIAL RANGE OF MOTION TEST, IT MAY NOT ONCE THE BSR STARTS TO DEGRADE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 24215977 ↗
• InjuryJan 29, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. APPROXIMATELY 4 WEEKS POST-OP, THE PATIENT EXPERIENCED AN ARTHROTOMY RUPTURE. IT WAS REPORTED TO SALES REP BY THE SURGEON THAT HE IS AN EXPERIENCED USER OF THE BARBED SUTURE FOR OVER 5 YEARS AND THOUSANDS OF CASES WITH NO ISSUES. THE SURGEON HAS HAD SOME ISSUES WITH THE BARBED SUTURE OVER THE PAST COUPLE MONTHS. IT WAS REPORTED THAT THE SURGEON RECENTLY CHANGED HIS TECHNIQUE AND CLOSED THE KNEE IN MAXIMUM EXTENSION. THEY DISCUSSED THE EMPHASIS IN PUTTING IN THE KNEE INTO FLEXION. IT WAS REPORTED THAT THE SURGEON TESTS THE KNEE THROUGH RANGE OF MOTION SO IT SHOULDN'T BE AN ISSUE. THE LOSS OF BSR OVER THE WEEKS WAS DISCUSSED AND THOUGH IT MAY BE STRONG ENOUGH TO HOLD FOR THE INITIAL RANGE OF MOTION TEST, IT MAY NOT ONCE THE BSR STARTS TO DEGRADE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 24215972 ↗
• InjuryJan 29, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. APPROXIMATELY 4 WEEKS POST-OP, THE PATIENT EXPERIENCED AN ARTHROTOMY RUPTURE. IT WAS REPORTED TO SALES REP BY THE SURGEON THAT HE IS AN EXPERIENCED USER OF THE BARBED SUTURE FOR OVER 5 YEARS AND THOUSANDS OF CASES WITH NO ISSUES. THE SURGEON HAS HAD SOME ISSUES WITH THE BARBED SUTURE OVER THE PAST COUPLE MONTHS. IT WAS REPORTED THAT THE SURGEON RECENTLY CHANGED HIS TECHNIQUE AND CLOSED THE KNEE IN MAXIMUM EXTENSION. THEY DISCUSSED THE EMPHASIS IN PUTTING IN THE KNEE INTO FLEXION. IT WAS REPORTED THAT THE SURGEON TESTS THE KNEE THROUGH RANGE OF MOTION SO IT SHOULDN'T BE AN ISSUE. THE LOSS OF BSR OVER THE WEEKS WAS DISCUSSED AND THOUGH IT MAY BE STRONG ENOUGH TO HOLD FOR THE INITIAL RANGE OF MOTION TEST, IT MAY NOT ONCE THE BSR STARTS TO DEGRADE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 24215969 ↗
• InjuryJan 29, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. APPROXIMATELY 4 WEEKS POST-OP, THE PATIENT EXPERIENCED AN ARTHROTOMY RUPTURE. IT WAS REPORTED TO SALES REP BY THE SURGEON THAT HE IS AN EXPERIENCED USER OF THE BARBED SUTURE FOR OVER 5 YEARS AND THOUSANDS OF CASES WITH NO ISSUES. THE SURGEON HAS HAD SOME ISSUES WITH THE BARBED SUTURE OVER THE PAST COUPLE MONTHS. IT WAS REPORTED THAT THE SURGEON RECENTLY CHANGED HIS TECHNIQUE AND CLOSED THE KNEE IN MAXIMUM EXTENSION. THEY DISCUSSED THE EMPHASIS IN PUTTING IN THE KNEE INTO FLEXION. IT WAS REPORTED THAT THE SURGEON TESTS THE KNEE THROUGH RANGE OF MOTION SO IT SHOULDN'T BE AN ISSUE. THE LOSS OF BSR OVER THE WEEKS WAS DISCUSSED AND THOUGH IT MAY BE STRONG ENOUGH TO HOLD FOR THE INITIAL RANGE OF MOTION TEST, IT MAY NOT ONCE THE BSR STARTS TO DEGRADE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 24215968 ↗
• InjuryJan 29, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. APPROXIMATELY 4 WEEKS POST-OP, THE PATIENT EXPERIENCED AN ARTHROTOMY RUPTURE. IT WAS REPORTED TO SALES REP BY THE SURGEON THAT HE IS AN EXPERIENCED USER OF THE BARBED SUTURE FOR OVER 5 YEARS AND THOUSANDS OF CASES WITH NO ISSUES. THE SURGEON HAS HAD SOME ISSUES WITH THE BARBED SUTURE OVER THE PAST COUPLE MONTHS. IT WAS REPORTED THAT THE SURGEON RECENTLY CHANGED HIS TECHNIQUE AND CLOSED THE KNEE IN MAXIMUM EXTENSION. THEY DISCUSSED THE EMPHASIS IN PUTTING IN THE KNEE INTO FLEXION. IT WAS REPORTED THAT THE SURGEON TESTS THE KNEE THROUGH RANGE OF MOTION SO IT SHOULDN'T BE AN ISSUE. THE LOSS OF BSR OVER THE WEEKS WAS DISCUSSED AND THOUGH IT MAY BE STRONG ENOUGH TO HOLD FOR THE INITIAL RANGE OF MOTION TEST, IT MAY NOT ONCE THE BSR STARTS TO DEGRADE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 24215966 ↗
• InjuryJan 29, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. APPROXIMATELY 4 WEEKS POST-OP, THE PATIENT EXPERIENCED AN ARTHROTOMY RUPTURE. IT WAS REPORTED TO SALES REP BY THE SURGEON THAT HE IS AN EXPERIENCED USER OF THE BARBED SUTURE FOR OVER 5 YEARS AND THOUSANDS OF CASES WITH NO ISSUES. THE SURGEON HAS HAD SOME ISSUES WITH THE BARBED SUTURE OVER THE PAST COUPLE MONTHS. IT WAS REPORTED THAT THE SURGEON RECENTLY CHANGED HIS TECHNIQUE AND CLOSED THE KNEE IN MAXIMUM EXTENSION. THEY DISCUSSED THE EMPHASIS IN PUTTING IN THE KNEE INTO FLEXION. IT WAS REPORTED THAT THE SURGEON TESTS THE KNEE THROUGH RANGE OF MOTION SO IT SHOULDN'T BE AN ISSUE. THE LOSS OF BSR OVER THE WEEKS WAS DISCUSSED AND THOUGH IT MAY BE STRONG ENOUGH TO HOLD FOR THE INITIAL RANGE OF MOTION TEST, IT MAY NOT ONCE THE BSR STARTS TO DEGRADE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pain; Wound Dehiscence

  MAUDE report 24215964 ↗
• InjuryJan 29, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. APPROXIMATELY 4 WEEKS POST-OP, THE PATIENT EXPERIENCED AN ARTHROTOMY RUPTURE. IT WAS REPORTED TO SALES REP BY THE SURGEON THAT HE IS AN EXPERIENCED USER OF THE BARBED SUTURE FOR OVER 5 YEARS AND THOUSANDS OF CASES WITH NO ISSUES. THE SURGEON HAS HAD SOME ISSUES WITH THE BARBED SUTURE OVER THE PAST COUPLE MONTHS. IT WAS REPORTED THAT THE SURGEON RECENTLY CHANGED HIS TECHNIQUE AND CLOSED THE KNEE IN MAXIMUM EXTENSION. THEY DISCUSSED THE EMPHASIS IN PUTTING IN THE KNEE INTO FLEXION. IT WAS REPORTED THAT THE SURGEON TESTS THE KNEE THROUGH RANGE OF MOTION SO IT SHOULDN'T BE AN ISSUE. THE LOSS OF BSR OVER THE WEEKS WAS DISCUSSED AND THOUGH IT MAY BE STRONG ENOUGH TO HOLD FOR THE INITIAL RANGE OF MOTION TEST, IT MAY NOT ONCE THE BSR STARTS TO DEGRADE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 24215963 ↗
• InjuryJan 29, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. APPROXIMATELY 4 WEEKS POST-OP, THE PATIENT EXPERIENCED AN ARTHROTOMY RUPTURE. IT WAS REPORTED TO SALES REP BY THE SURGEON THAT HE IS AN EXPERIENCED USER OF THE BARBED SUTURE FOR OVER 5 YEARS AND THOUSANDS OF CASES WITH NO ISSUES. THE SURGEON HAS HAD SOME ISSUES WITH THE BARBED SUTURE OVER THE PAST COUPLE MONTHS. IT WAS REPORTED THAT THE SURGEON RECENTLY CHANGED HIS TECHNIQUE AND CLOSED THE KNEE IN MAXIMUM EXTENSION. THEY DISCUSSED THE EMPHASIS IN PUTTING IN THE KNEE INTO FLEXION. IT WAS REPORTED THAT THE SURGEON TESTS THE KNEE THROUGH RANGE OF MOTION SO IT SHOULDN'T BE AN ISSUE. THE LOSS OF BSR OVER THE WEEKS WAS DISCUSSED AND THOUGH IT MAY BE STRONG ENOUGH TO HOLD FOR THE INITIAL RANGE OF MOTION TEST, IT MAY NOT ONCE THE BSR STARTS TO DEGRADE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pain; Wound Dehiscence

  MAUDE report 24215962 ↗
• InjuryJan 29, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. APPROXIMATELY 4 WEEKS POST-OP, THE PATIENT EXPERIENCED AN ARTHROTOMY RUPTURE. IT WAS REPORTED TO SALES REP BY THE SURGEON THAT HE IS AN EXPERIENCED USER OF THE BARBED SUTURE FOR OVER 5 YEARS AND THOUSANDS OF CASES WITH NO ISSUES. THE SURGEON HAS HAD SOME ISSUES WITH THE BARBED SUTURE OVER THE PAST COUPLE MONTHS. IT WAS REPORTED THAT THE SURGEON RECENTLY CHANGED HIS TECHNIQUE AND CLOSED THE KNEE IN MAXIMUM EXTENSION. THEY DISCUSSED THE EMPHASIS IN PUTTING IN THE KNEE INTO FLEXION. IT WAS REPORTED THAT THE SURGEON TESTS THE KNEE THROUGH RANGE OF MOTION SO IT SHOULDN'T BE AN ISSUE. THE LOSS OF BSR OVER THE WEEKS WAS DISCUSSED AND THOUGH IT MAY BE STRONG ENOUGH TO HOLD FOR THE INITIAL RANGE OF MOTION TEST, IT MAY NOT ONCE THE BSR STARTS TO DEGRADE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 24215961 ↗
• InjuryJan 29, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. APPROXIMATELY 4 WEEKS POST-OP, THE PATIENT EXPERIENCED AN ARTHROTOMY RUPTURE. IT WAS REPORTED TO SALES REP BY THE SURGEON THAT HE IS AN EXPERIENCED USER OF THE BARBED SUTURE FOR OVER 5 YEARS AND THOUSANDS OF CASES WITH NO ISSUES. THE SURGEON HAS HAD SOME ISSUES WITH THE BARBED SUTURE OVER THE PAST COUPLE MONTHS. IT WAS REPORTED THAT THE SURGEON RECENTLY CHANGED HIS TECHNIQUE AND CLOSED THE KNEE IN MAXIMUM EXTENSION. THEY DISCUSSED THE EMPHASIS IN PUTTING IN THE KNEE INTO FLEXION. IT WAS REPORTED THAT THE SURGEON TESTS THE KNEE THROUGH RANGE OF MOTION SO IT SHOULDN'T BE AN ISSUE. THE LOSS OF BSR OVER THE WEEKS WAS DISCUSSED AND THOUGH IT MAY BE STRONG ENOUGH TO HOLD FOR THE INITIAL RANGE OF MOTION TEST, IT MAY NOT ONCE THE BSR STARTS TO DEGRADE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 24215960 ↗
• InjuryJan 29, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. APPROXIMATELY 4 WEEKS POST-OP, THE PATIENT EXPERIENCED AN ARTHROTOMY RUPTURE. IT WAS REPORTED TO SALES REP BY THE SURGEON THAT HE IS AN EXPERIENCED USER OF THE BARBED SUTURE FOR OVER 5 YEARS AND THOUSANDS OF CASES WITH NO ISSUES. THE SURGEON HAS HAD SOME ISSUES WITH THE BARBED SUTURE OVER THE PAST COUPLE MONTHS. IT WAS REPORTED THAT THE SURGEON RECENTLY CHANGED HIS TECHNIQUE AND CLOSED THE KNEE IN MAXIMUM EXTENSION. THEY DISCUSSED THE EMPHASIS IN PUTTING IN THE KNEE INTO FLEXION. IT WAS REPORTED THAT THE SURGEON TESTS THE KNEE THROUGH RANGE OF MOTION SO IT SHOULDN'T BE AN ISSUE. THE LOSS OF BSR OVER THE WEEKS WAS DISCUSSED AND THOUGH IT MAY BE STRONG ENOUGH TO HOLD FOR THE INITIAL RANGE OF MOTION TEST, IT MAY NOT ONCE THE BSR STARTS TO DEGRADE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 24215954 ↗
• InjuryJan 29, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. APPROXIMATELY 4 WEEKS POST-OP, THE PATIENT EXPERIENCED AN ARTHROTOMY RUPTURE. IT WAS REPORTED TO SALES REP BY THE SURGEON THAT HE IS AN EXPERIENCED USER OF THE BARBED SUTURE FOR OVER 5 YEARS AND THOUSANDS OF CASES WITH NO ISSUES. THE SURGEON HAS HAD SOME ISSUES WITH THE BARBED SUTURE OVER THE PAST COUPLE MONTHS. IT WAS REPORTED THAT THE SURGEON RECENTLY CHANGED HIS TECHNIQUE AND CLOSED THE KNEE IN MAXIMUM EXTENSION. THEY DISCUSSED THE EMPHASIS IN PUTTING IN THE KNEE INTO FLEXION. IT WAS REPORTED THAT THE SURGEON TESTS THE KNEE THROUGH RANGE OF MOTION SO IT SHOULDN'T BE AN ISSUE. THE LOSS OF BSR OVER THE WEEKS WAS DISCUSSED AND THOUGH IT MAY BE STRONG ENOUGH TO HOLD FOR THE INITIAL RANGE OF MOTION TEST, IT MAY NOT ONCE THE BSR STARTS TO DEGRADE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 24215949 ↗
• MalfunctionJan 12, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE TIP WE HAD THE TIP OF THE SUTURE BREAK OFF DURING CLOSURE OF A SURGICAL CASE. IT WAS FOUND TO BE A 1MM SIZE PART OF THE TIP UPON XRAY AFTER SURGERY. THERE WAS NO SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24037170 ↗
• MalfunctionDec 24, 2025Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT A FINAL FUSION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE SURGEON WAS ON THE LAST PASS WHEN THE SUTURE BROKE IN HALF. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888755 ↗
• MalfunctionDec 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. NEEDLE BREAKAGE DURING USE. ACCORDING TO HCP, APPROXIMATELY 30 TIMES. A SMALL PIECE OF THE TIP BROKE OFF. ALL THE TIPS WERE SUCCESSFULLY REMOVED FROM THE PATIENT; NO PART REMAIN IN PATIENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23854236 ↗