TWINFIX 72202600Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 03596010647481), received between Sep 21, 2017 and Aug 1, 2023 — classified as 3 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Break” (11 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 1, 2023Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY, THE TWINFIX ULTRA ANCHOR BROKE. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17436251 ↗
• MalfunctionFeb 1, 2023Break; Break

  IT WAS REPORTED THAT DURING AN RM SUTURE PROCEDURE, THE TIP OF THE TWINFIX ULTRA ANCHOR WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16277940 ↗
• InjuryJan 31, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TIP OF THE TWINFIX ULTRA WAS BROKEN AFTER IT WAS TAKEN OUT OF THE PACKAGING AND PARTS FELL INSIDE THE PATIENT. THE BROKEN PARTS WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16272831 ↗
• InjuryApr 13, 2022Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE TWINFIX ANCHOR BROKE FROM THE TIP WHILE DEPLOYMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14094062 ↗
• InjuryMar 21, 2021Crack; Crack

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR PROCEDURE, THE SURGEON USED AN S+N 3.8MM DISPOSABLE AWL TO PREPARE A BONE HOLE IN ORDER TO REPAIR THE PATIENT'S ROTATOR CUFF TENDON, THEN WHILE THE "5.5MM TWINFIX ULTRA PK ANCHOR" WAS BEING INSERTED, IT CRACKED ON THE DISTAL PART AND IT WAS SUCCESSFULLY REMOVED BY THE SURGEON USING TWEEZERS. NO PIECES OF SHRAPNEL WERE LEFT INSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11536936 ↗
• MalfunctionMar 12, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SHOULDER ARTHROSCOPY THE SUTURE ANCHOR BROKE. ALL PIECES WERE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9826485 ↗
• MalfunctionMar 12, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SHOULDER ARTHROSCOPY THE SUTURE ANCHOR BROKE. ALL PIECES WERE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9826379 ↗
• MalfunctionMar 12, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SHOULDER ARTHROSCOPY THE SUTURE ANCHOR BROKE. ALL PIECES WERE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9826274 ↗
• MalfunctionMar 12, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SHOULDER ARTHROSCOPY THE SUTURE ANCHOR BROKE. ALL PIECES WERE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9826248 ↗
• MalfunctionMar 9, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SURGERY, THE TIP OF THE ANCHOR BROKE WHILE BEING INSERTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9809067 ↗
• MalfunctionNov 11, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A SHOULDER CASE ANCHOR BROKE DURING INSERTION, ALL PIECES WERE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9307521 ↗
• MalfunctionAug 19, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR PROCEDURE, THE SURGEON USED A 3.8 MM REUSABLE GOLDEN AWL TO MAKE PILOT HOLE FOR THE ANCHOR. THEN INSERTED THE ANCHOR INTO THE PILOT HOLE, HOWEVER, WHEN PARTWAY THROUGH ANCHOR INSERTION, THE DISTAL TIP OF THE ANCHOR SNAPPED WHILE INSIDE OF THE PATIENT. ALL OF THE DEVICE WAS RETRIEVED FROM THE PATIENT. A BACK-UP DEVICE WAS USED, IN THE SAME BONE HOLE, TO COMPLETE THE PROCEDURE. NO SURGICAL DELAY OR PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8908420 ↗
• MalfunctionFeb 26, 2019Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR SURGERY, THE TWINFIX ULTRA ANCHOR BROKE ABOVE THE EYELET WHILE BEING INSERTED. THE FRAGMENTS WERE REMOVED FROM THE PATIENT, BUT IT IS UNKNOWN HOW. A S&N BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE, BUT IT IS UNKNOWN WHETHER IT WAS NECESSARY TO DRILL ANOTHER BONE HOLE TO USE IT. NEITHER SIGNIFICANT SURGICAL DELAY NOR PATIENT INJURIES WERE DISCLOSED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8372426 ↗
• MalfunctionFeb 12, 2019Break

  IT WAS REPORTED THAT DURING APPLICATION THE DEVICE BREAK IN THE SUTURE EYELET. THE DAMAGED DEVICE COULD BE REMOVED FROM THE PATIENT AND REPLACED BY A NEW ONE. THE REPORTED DELAY RESULTED IN TEN MINUTES EXTENDED EXPOSURE TO ANESTHESIA. NO SIGNIFICANT DELAY OR PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8333407 ↗
• MalfunctionDec 26, 2018Break

  IT WAS REPORTED THAT DURING PROCEDURE, THE TIP OF THE ANCHOR BROKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8198165 ↗
• MalfunctionNov 11, 2018Break

  IT WAS REPORTED THAT DURING APPLICATION, THE DEVICE BROKE. THE DAMAGED DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW ONE IN THE SAME BONE HOLE. NO SIGNIFICANT DELAY OR PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8058438 ↗
• MalfunctionAug 1, 2018Break

  IT WAS REPORTED THAT DURING APPLICATION OF THE ANCHOR, IT BROKE. THE HOLE WAS PREPARED WITH THE 3,8 MM AWL. NO PATIENT INJURIES AND MINOR DELAY WERE REPORTED. A BACKUP WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7739213 ↗
• MalfunctionJan 5, 2018Break

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF THE ANCHOR, THE TWINFIX ULTRA BROKE. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7167720 ↗
• MalfunctionSep 21, 2017Break

  IT WAS REPORTED THAT WHEN SCREWING IN THE ANCHOR, THE PEAK BROKE. ALL BROKEN PIECES WERE REMOVED FROM THE SURGICAL SITE. PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6885053 ↗