TWINFIX 72202615Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 03596010656209), received between Apr 25, 2018 and Mar 2, 2026 — classified as 5 injuries, 16 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, IT WAS NOTICED THAT TWO (2) TWINFIX ULTRA ANCHORS SNAPPED WHEN ATTEMPTING TO INSERT THEM INTO THE BONE SURFACE, AS BONE QUALITY WAS VERY HARD. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY OR HOW THE PROCEDURE WAS PERFORMED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24479999 ↗
• MalfunctionJan 13, 2026Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF TEAR PROCEDURE, IT WAS NOTICED THAT THE TWIN FIX ULTRA PK 5.5MM GOT BROKEN WHILE DEPLOYING IT. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT SURGICAL DELAY, USING A SIMILAR SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24053054 ↗
• MalfunctionDec 15, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TIP OF THE TWINFIX 5.5MM PK ANCHOR BROKE WHEN SCREWING IN THE PCL GRAFT. THE BROKEN PIECES WERE REMOVED FROM INSIDE THE PATIENT USING TWEEZERS. THE INSERTION SITE WAS CLEARED AS THIS IS THE LAST STEP TO SECURE THE PCL GRAFT TO THE BONE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP PRODUCT INSERTED INTO THE ORIGINAL BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23803700 ↗
• MalfunctionOct 23, 2025Break; Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR PROCEDURE, WHILE DEPLOYING, THE TWINFIX ULTRA ANCHOR GOT BROKEN. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23366527 ↗
• InjuryJun 5, 2023Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE TWINFIX ANCHOR BROKE. HALF THE ANCHOR WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 17066035 ↗
• InjuryDec 13, 2021Break; Break

  IT WAS REPORTED THAT DURING THE USE OF INSTRUMENTS INSIDE THE PATIENT IN AN MCL RECONSTRUCTION, THE SURGEON PREPARED THE BONE AND THEN ATTEMPTED TO USE THE TWINFIX ANCHOR. THE ANCHOR BROKE UPON ATTEMPTING TO INTRODUCE INTO THE BONE. ALL BROKEN PIECES WERE REMOVED BY HAND. THE SURGEON THEN CHOSE A TWINFIX TI ANCHOR WHICH WORKED SUCCESSFULLY. THE ANCHOR WAS USED IN THE ORIGINAL HOLE PREPARED. NON-SIGNIFICANT DELAY WAS REPORTED, AND NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12990826 ↗
• InjuryDec 13, 2021Break; Break

  IT WAS REPORTED THAT DURING THE USE OF INSTRUMENTS INSIDE THE PATIENT IN AN MCL RECONSTRUCTION, THE SURGEON PREPARED THE BONE AND THEN ATTEMPTED TO USE THE TWINFIX ANCHOR. THE ANCHOR BROKE UPON ATTEMPTING TO INTRODUCE INTO THE BONE. ALL BROKEN PIECES WERE REMOVED BY HAND. THE SURGEON THEN CHOSE A TWINFIX TI ANCHOR WHICH WORKED SUCCESSFULLY. THE ANCHOR WAS USED IN THE ORIGINAL HOLE PREPARED. NON-SIGNIFICANT DELAY WAS REPORTED, AND NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12990799 ↗
• MalfunctionJul 16, 2021Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT AFTER A PROXIMAL HAMSTRING REPAIR, TWINFIX ULTRA DEVICE HAD A LABELING ISSUE, SINCE IT APPEARED TO BE A 4.5MM AND IT WAS A 5.5MM. IN ADDITION IT WAS NOTICED THAT DEVICE WAS USED EXPIRED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12185541 ↗
• MalfunctionJul 16, 2021Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT AFTER A PROXIMAL HAMSTRING REPAIR, TWINFIX ULTRA DEVICE HAD A LABELING ISSUE, SINCE IT APPEARED TO BE A 4.5MM AND IT WAS A 5.5MM. IN ADDITION IT WAS NOTICED THAT DEVICE WAS USED EXPIRED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12185529 ↗
• InjuryMay 17, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE TWINFIX BROKE UPON INSERTION. THE PROCEDURE WAS COMPLETED WITH A DELAY OF 30 MINUTES OR LESS USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11836366 ↗
• InjuryMay 21, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY, UPON INSERT THE ANCHOR INTO THE PATIENT, THE TIP OF THE ANCHOR BROKE AND THEN IT WAS REMOVED FROM PATIENT WITH A KNIFE AND ARTERY CLAMP. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO SIGNIFICANT DELAY AND NO PATIENT INJURIES WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10080830 ↗
• MalfunctionJan 8, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ANKLE TENDON ACHILLES REPAIR, WHEN USING A TWINFIX ULTRA, THE TIP OF THE SUTURE ANCHOR BROKE WHEN BEING INSERTING INTO THE PATIENT METATARSAL BONE. THE PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE IN THE SAME BONE HOLE. 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: Foreign Body In Patient

  MAUDE report 9566309 ↗
• MalfunctionDec 24, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SURGERY ANCHOR BROKE ABOUT 3-4 MM FROM THE TIP AFTER BARELY TWO TURNS, A 3.8 TAPERED AWL WAS USED, ANOTHER BONE HOLE HAD TO BE DRILLED IN THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY 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 9516113 ↗
• MalfunctionSep 24, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING THE SURGERY THE ANCHOR BROKE ITS TIP UPON INSERTION INTO THE BONE, WITH MINIMAL FORCE APPLIED. THE BROKEN PIECE WAS REMOVED FROM THE PATIENT WITH A GRASPER. A BACKUP DEVICE WAS USED TO COMPLETE THE SURGERY. NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9112296 ↗
• MalfunctionSep 24, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING THE SURGERY THE ANCHOR BROKE ITS TIP UPON INSERTION INTO THE BONE, WITH MINIMAL FORCE APPLIED. THE BROKEN PIECE WAS REMOVED FROM THE PATIENT WITH A GRASPER. A BACKUP DEVICE WAS USED TO COMPLETE THE SURGERY. NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9112222 ↗
• MalfunctionSep 19, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING THE SURGERY THE ANCHOR BROKE ITS TIP UPON INSERTION INTO THE BONE, WITH MINIMAL FORCE APPLIED. THE BROKEN PIECE WAS REMOVED FROM THE PATIENT WITH A GRASPER. A BACKUP DEVICE WAS USED TO COMPLETE THE SURGERY. NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9090303 ↗
• MalfunctionFeb 5, 2019Break; Material Puncture/Hole

  IT WAS REPORTED THAT, DURING A SHOULDER ROTATOR CUFF REPAIR SURGERY, THE NON-BIOABSORBABLE TWINFIX ULTRA SUTURE ANCHOR TIP BROKE WHILE INSERTED INTO THE PATIENT BONE. A BACK-UP WAS AVAILABLE AND USED IN THE SAME BONE HOLE, BUT FACED THE SAME FAITH. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MIN. NO PATIENT INJURIES HAVE BEEN STATED. FOR PREPARATION OF THE INSERTION SITE, IT WAS USED A 3.8 MM GOLD DILATOR; PATIENT BONE QUALITY WAS DESCRIBED AS HARD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8308586 ↗
• MalfunctionFeb 5, 2019Break

  IT WAS REPORTED THAT, DURING A SHOULDER ROTATOR CUFF REPAIR SURGERY, THE NON-BIOABSORBABLE TWINFIX ULTRA SUTURE ANCHOR TIP BROKE WHILE INSERTED INTO THE PATIENT BONE. A BACK-UP WAS AVAILABLE AND USED IN THE SAME BONE HOLE. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MIN. NO PATIENT INJURIES HAVE BEEN STATED. FOR PREPARATION OF THE INSERTION SITE, IT WAS USED A 3.8 MM GOLD DILATOR; PATIENT BONE QUALITY WAS DESCRIBED AS HARD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8308585 ↗
• MalfunctionDec 12, 2018Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SURGEON TAPPED THE HOLE FOR THE TWINFIX PK ANCHOR WITH THE 4.5MM HEALICOIL TAP AS PER HER PREFERENCE. WHEN SHE TURNED THE ANCHOR INTO THE PRE-TAPPED HOLE, THE ANCHOR BROKE IN HALF. ANOTHER ANCHOR WAS PROVIDED, THE 5.5MM TWINFIX AWL WAS USED AND THE SECOND ANCHOR WORKED PERFECTLY. THERE WAS NO SIGNIFICANT DELAY AND NO PATIENT INJURIES.

  Patient problems: No Code Available

  MAUDE report 8155657 ↗
• MalfunctionApr 26, 2018Break

  IT WAS REPORTED THAT THE ANCHORS BROKEN DURING INSERTION INTO PATIENT HUMERUS (SHOULDER ROTATOR CUFF REPAIR). THE 3.8MM DILATOR USED PRIOR IMPLANTATION OF THE SUTURE ANCHORS. BOTH 1ST AND 2ND ANCHORS BROKEN DURING SCREWING INTO HUMERUS. TWINFIX TI 5.0 MM SUTURE ANCHOR WAS USED THEN. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7466571 ↗
• MalfunctionApr 25, 2018Break

  IT WAS REPORTED THAT THE ANCHOR BROKE DURING INSERTION INTO PATIENT HUMERUS. A 3.8MM DILATOR WAS USED PRIOR IMPLANTATION OF THE SUTURE ANCHOR. NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7463225 ↗