TWINFIX 72202625Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 03596010647535), received between Nov 16, 2018 and Aug 25, 2025 — classified as 5 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Break” (16 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.

• MalfunctionAug 25, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, ONE (1) TWINFIX ULTRA PEEK BROKE DURING INSERTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A BACK-UP DEVICE IN A NEW BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 22890299 ↗
• MalfunctionMay 1, 2025Break; Crack; Break; Crack

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, AFTER DEPLOYMENT OF THE TWINFIX, THE ANCHOR BROKE. THE CRACKED PIECES WERE NOT REMOVED FROM PATIENT BECAUSE THE ANCHOR WAS CRACKED INSIDE THE BONE HOLE, NOT SHATTERED, SO THE SURGEON DID NOT WANT TO REMOVE THE PIECES AS THE PIECES WONT CAME OUT OF THE BONE HOLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE ON THE ORIGINALLY DRILLED BONE HOLE OF 5.0 MM, MADE WITH AN 5.5MM GOLDEN AWL.NO FURTHER COMPLICATIONS WERE REPORTED, THE PATIENT CONDITION IS STABLE.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21944827 ↗
• MalfunctionDec 3, 2024Break; Break

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED PROCEDURE, THE TWINFIX ULTRA TIP GOT BROKEN. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20839693 ↗
• MalfunctionMay 13, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE DISTAL TIP OF THE TWINFIX BROKE WHILE DEPLOYMENT OF THE ANCHOR. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT WITH TWEEZERS. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE IN THE INITIAL BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19298122 ↗
• MalfunctionAug 18, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, TWO TWINFIX ULTRA ANCHORS FAILED IN THE SAME WAY. WHILE DEPLOYING EACH ANCHOR, THE TIP FROM THE DEVICE BROKE. THE BROKEN TIP WAS REMOVED FROM THE PATIENT'S BODY BY GRASPER. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17578710 ↗
• InjurySep 23, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE TIP OF THE TWINFIX PK SUTURE ANCHOR BROKE WHILE DEPLOYING IT. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT SURGICAL DELAY, USING A BACK-UP DEVICE INSTEAD. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15470473 ↗
• InjurySep 5, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TWINFIX ANCHOR TIP GOT BROKEN WHILE DEPLOYING. THE BROKEN HALF IMPLANTS WERE REMOVED FROM PATIENT WITH GRASPERS. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. THE CURRENT STATUS OF THE PATIENT IS NORMAL AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15357359 ↗
• InjuryFeb 11, 2022Break; Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, THE TWINFIX ANCHOR BROKE WHILE BEING INTRODUCED INTO THE BONE. ALL THE BROKEN PIECES WERE RETRIEVED WITH A SUTURE MANIPULATOR/GRABBER. THIS ISSUE LEAD TO A SURGICAL DELAY GREATER THAN 30 MINUTES, THE PROCEDURE WAS FINISHED WITH THE 2/3 OF THE LENGTH OF THE ANCHOR THAT BROKE AND A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT STATUS IS GOOD, THE CUFF TEAR HEALED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13511209 ↗
• InjuryOct 4, 2021Break; Break

  IT WAS REPORTED THAT DURING USE IN AN UNSPECIFIED PROCEDURE, THE ANCHOR BROKE DURING DEPLOYMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12568581 ↗
• MalfunctionSep 4, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, THE ANCHOR DID NOT MAINTAIN THE STRUCTURAL INTEGRITY WHEN SCREWING INTO THE HUMERAL HEAD OF THE PATIENT, CRACKING UNDER PRESSURE OF CORTICAL BONE, DESPITE REPORTEDLY DILATING BONE CORRECTLY WITH 3.8 MM TAPERED AWL DILATOR. ALL THE PIECES WERE REMOVED. THE PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE WITH NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8962574 ↗
• MalfunctionSep 2, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, THE ANCHOR DID NOT MAINTAIN THE STRUCTURAL INTEGRITY WHEN SCREWING INTO THE HUMERAL HEAD OF THE PATIENT, CRACKING UNDER PRESSURE OF CORTICAL BONE, DESPITE REPORTEDLY DILATING BONE CORRECTLY WITH 3.8 MM TAPERED AWL DILATOR. ALL THE PIECES WERE REMOVED. THE PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE WITH NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8954188 ↗
• MalfunctionApr 30, 2019Break; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING A PROCEDURE THE ANCHOR SNAPPED DURING INSERTION INTO BONE. NO PATIENT INJURIES REPORTED AND NO DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME DEVICE. ALL THE PIECES FROM THE LOOSE BODY ANCHOR WERE RETRIEVED WITH A ARTHROSCOPIC GRASPER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8565787 ↗
• InjuryMar 25, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ROTATOR CUFF SURGERY WAS PERFORMED IN 2013. MRI WAS PERFORMED ON THE SHOULDER BECAUSE PAIN WAS REPORTED, THERE WAS CYSTS AROUND ONE AND POSSIBLY TWO OF THE ANCHORS. S.A.D WAS PERFORMED BUT THE PRODUCT WAS NOT REMOVED FROM THE PATIENT. DEVICE WILL NOT BE RETURNED.

  Patient problems: Cyst(s); Pain

  MAUDE report 8449672 ↗
• MalfunctionMar 14, 2019Crack; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING ROTATOR CUFF REPAIR, THE TWINFIX ANCHOR CRACKED WITH PIECE FALLING OFF IT AS WAS BEING SCREWED IN TO PLACE. THE LOOSE PIECE WAS REMOVED. THE REST OF THE IMPLANT STAYED IN AND WAS USED TO SECURE THE CUFF DOWN. DELAY OR PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8423065 ↗
• MalfunctionMar 14, 2019Crack; Loose or Intermittent Connection; Device Fell

  IT WAS REPORTED THAT DURING ROTATOR CUFF REPAIR, THE TWINFIX ANCHOR CRACKED WITH PIECE FALLING OFF IT AS WAS BEING SCREWED IN TO PLACE. THE LOOSE PIECE WAS REMOVED. THE REST OF THE IMPLANT STAYED IN AND WAS USED TO SECURE THE CUFF DOWN. DELAY OR PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8423048 ↗
• MalfunctionFeb 11, 2019Break

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY, THE ANCHOR BROKE WHILE SCREWED IN. ALL THE PIECES WERE REMOVED. THERE WAS NO LOSS OF TISSUE OR BONE DUE TO THE EVENT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY AND NO PATIENT INJURIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8325184 ↗
• MalfunctionFeb 11, 2019Break

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY, THE ANCHOR BROKE WHILE SCREWED IN. ALL THE PIECES WERE REMOVED. THERE WAS NO LOSS OF TISSUE OR BONE DUE TO THE EVENT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY AND NO PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8325168 ↗
• MalfunctionFeb 6, 2019Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, THE TWINFIX ULTRA SCREW TIP BROKE OFF. AFTER PUSHED THE POSITION WITH THE CORRESPONDING AWL, THE IMPLANT IS TORN IN THE MIDDLE WHEN SCREWING IT INTO THE BONE. THE PIECE FRAGMENTS WERE COMPLETELY REMOVED FROM THE PATIENT WITHOUT ANY PROBLEM. A S&N BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NEITHER SIGNIFICANT SURGICAL DELAY NOR PATIENT INJURIES HAVE BEEN STATED. THE PATIENT BONE QUALITY WAS A VERY SOFT; THE AWL COULD HAVE BEEN INSERTED INTO THE BONE TO THE DESIRED MARK WITHOUT A HAMMER. NEVERTHELESS, FOR INSERTION SITE PREPARATION, IT WAS USED THE S&N MATCHING AWL WITH A HAMMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8310011 ↗
• MalfunctionFeb 6, 2019Break; Detachment of Device or Device Component; Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, THE TWINFIX ULTRA SCREW TIP BROKE OFF. AFTER PUSHED THE POSITION WITH THE CORRESPONDING AWL, THE IMPLANT IS TORN IN THE MIDDLE WHEN SCREWING IT INTO THE BONE. THE PIECE FRAGMENTS WERE COMPLETELY REMOVED FROM THE PATIENT WITHOUT ANY PROBLEM. A S&N BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NEITHER SIGNIFICANT SURGICAL DELAY NOR PATIENT INJURIES HAVE BEEN STATED. THE PATIENT BONE QUALITY WAS A VERY SOFT; THE AWL COULD HAVE BEEN INSERTED INTO THE BONE TO THE DESIRED MARK WITHOUT A HAMMER. NEVERTHELESS, FOR INSERTION SITE PREPARATION, IT WAS USED THE S&N MATCHING AWL WITH A HAMMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8310010 ↗
• MalfunctionNov 23, 2018Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE ANCHOR BROKE WHEN SCREWED IN. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8100018 ↗
• MalfunctionNov 16, 2018Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE ANCHOR BROKE WHEN SCREWED IN. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8080708 ↗