TWINFIX 72202597Recalls & reported problems

Summary

The FDA's MAUDE database contains 288 adverse event reports that list this exact device (DI 03596010647559), received between Mar 28, 2018 and May 31, 2026 — classified as 113 injuries, 175 malfunctions.

The most frequently reported specific device problem is “Break” (224 reports).

40 other recalls cover devices cleared under the same FDA submission (K151105); they may or may not involve this specific model.

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 288 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 31, 2026Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF SURGERY, AFTER THE INSERTION SITE WAS CLEARED OF ALL DEBRIS, WHEN WAS INSIDE THE PATIENT, THE SUTURE AND THE HEAD OF TWO (2) TWINFIX ULTRA ANCHORS BROKE. ALL THE PIECES WERE REMOVED FROM THE PATIENT WITH TWEEZERS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. THE BACK-UP DEVICE WAS USED IN THE ORIGINALLY DRILLED BONE HOLE. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25345332 ↗
• MalfunctionMay 11, 2026Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, AFTER INSERTING THE TWINFIX ANCHOR, IT BROKE INSIDE THE PATIENT. THE SURGEON FOLLOWED THE CORRECT TECHNIQUE, AND EVEN SO, IT BROKE. THE ANCHOR WAS DAMAGED INSIDE THE PATIENT, BUT IT WAS HELD IN PLACE BY THE ANCHOR WIRES; IT WAS REMOVED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25145650 ↗
• MalfunctionMay 3, 2026Fracture

  IT WAS REPORTED THAT, DURING A SURGERY, THE HEAD OF THE TWINFIX ANCHOR WAS FRACTURED WHEN SCREWING IN. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT SN BACK UP DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25062900 ↗
• MalfunctionApr 18, 2026Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY, THE END OF THE TWINFIX ULTRA ANCHOR BROKE. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACKUP. IT IS UNKNOWN WHETHER ANY DELAY OCCURRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24919926 ↗
• MalfunctionApr 8, 2026Break

  IT WAS REPORTED THAT, DURING A SURGERY, IT WAS NOTICED THAT AFTER OPENING THE WAY WITH A 4.5 TAP, USED THE BLADES TO POLISH THE BONE TUNNEL, THE TWINFIX ANCHOR BROKE DURING IMPLANTATION. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK UP DEVICE. ALL PIECES WERE REMOVED FORM THE PATIENT USING TWEEZERS. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24818268 ↗
• MalfunctionMar 31, 2026Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR SURGERY, AFTER OPENING THE HOLE WITH THE 4.5 TAP, THE TWINFIX ANCHOR BROKE WHEN SCREWED IN. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING AN EQUIVALENT S&N BACK-UP DEVICE IN THE ORIGINAL BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24742297 ↗
• MalfunctionMar 24, 2026Break; Material Deformation

  IT WAS REPORTED THAT DURING A PATELLAR REALIGNMENT PROCEDURE, AFTER CLAMPING THE AREA, THE TWINFIX ANCHOR WAS INSERTED WITH EXCESSIVE FORCE, THE TIP BROKE, LOOSENING THE SUTURES. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24674422 ↗
• MalfunctionMar 23, 2026Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF PROCEDURE, A TWINFIX ULTRA HA 4.5 W/2 UB WH & BLUE WAS FRACTURED. THE INSERTION SITE WAS CLEARED OF ALL DEBRIS PRIOR TO INSERTION, AND ALL THE PIECES WERE REMOVED FROM THE PATIENT WITH FORCEPS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24665235 ↗
• MalfunctionMar 4, 2026Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, A TWINFIX ULTRA HA 4.5 W/2 UB (WH & BLUE FRACTURED DURING IMPACT. THE INSERTION SITE WAS CLEARED OF ALL DEBRIS PRIOR TO INSERTION AND THE ALL THE PIECES WERE REMOVED FROM THE PATIENT WITH SUCTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK UP USED IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED AND PATIENT STATUS IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24507518 ↗
• MalfunctionFeb 9, 2026Fracture; Material Deformation

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, IT WAS NOTICED THAT THE TWINFIX ULTRA ANCHOR WAS FRACTURED. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT SURGICAL DELAY, USING AN EQUIVALENT S+N BACK UP PRODUCT ON THE ORIGINAL DRILLED BONE HOLE, LEAVING NO VOID IN THE PATIENT. PATIENT IS FINE AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24299359 ↗
• MalfunctionFeb 9, 2026Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR SURGERY, ONE (1) TWINFIX ULTRA WAS BROKEN DURING IMPLANTATION. AFTER REMOVAL OF THE BROKEN ANCHOR WITH TWEEZERS, ANOTHER ANCHOR WAS IMPLANTED AT THE SAME LOCATION, NO VOID WAS LEFT IN THE PATIENT. THE PROCEDURE WAS RESUMED, WITH A 5-MINUTE SURGICAL DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24299023 ↗
• MalfunctionFeb 2, 2026Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, THE TWINFIX ULTRA ANCHOR BURST. ALL THE PIECES WERE REMOVED WITH TWEEZERS AND SUCTION. THE PROCEDURE WAS RESUMED, WITHOUT DELAY, USING AN EQUIVALENT SN BACK-UP. THE BACK UP DEVICE WAS USED IN THE ORIGINALLY DRILLED BONE HOLE; THERE WERE NO VOIDS LEFT. THE INSTRUMENT TO PREPARE THE INSERTION SITE WAS AN ANCHOR MATCHING INSTRUMENT AND THE SITE WAS CLEARED OF ALL DEBRIS PRIOR TO THE INSERTION. THE PATIENT STATUS WAS FINE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24241281 ↗
• MalfunctionJan 22, 2026Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF SURGERY, IT WAS NOTICED THAT THE TWINFIX ANCHOR DEFORMED AND BROKE. SOME OF THE ANCHOR WAS REMOVED, BROKEN PIECES WERE LEFT INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A 20-MINUTE DELAY, USING AN EQUIVALENT S+N BACK UP DEVICE. THE BACK-UP DEVICE WAS USED IN THE ORIGINALLY DRILLED BONE HOLE, SO NO VOID WAS LEFT IN THE PATIENT. NO ADDITIONAL ANESTHESIA WAS NEEDED. NO FURTHER COMPLICATIONS WERE REPORTED.

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

  MAUDE report 24148692 ↗
• MalfunctionJan 16, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE FRONT PART OF THE TWINFIX ULTRA ANCHOR BROKE DURING IMPLANTATION. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACKUP INSERTED INTO THE ORIGINAL BONE HOLE, AFTER A NON-SIGNIFICANT DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24093622 ↗
• MalfunctionJan 13, 2026Fracture

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, THE TWINFIX ANCHOR FRACTURED. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING AN EQUIVALENT S&N BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24059182 ↗
• MalfunctionDec 29, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC EXAMINATION OF THE SHOULDER JOINT, IT WAS NOTICED THAT THE TWO TWIN-FIX ULTRA THAT WERE IMPLANTED BROKE AT THE HEAD AND THREAD JUNCTION. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK UP DEVICE. ALL PIECES WERE REMOVED USING FORCEPS, TWEEZERS AND SUCTION. THE BACK UP DEVICE WAS USED IN A NEW BONE HOLE. THE THIRD BIGGER ANCHOR WAS IMPLANTED IN THE ORIGINAL HOLE. NO ADDITIONAL ANESTHESIA WAS REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 23919096 ↗
• MalfunctionDec 29, 2025Break; Break

  IT WAS REPORTED THAT, DURING A SURGERY, THE ANCHOR OF ONE (1) TWINFIX ULTRA WAS BROKEN. IT IS UNKNOWN WHETHER THIS ISSUE CAUSED ANY SURGICAL DELAY; HOWEVER, THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23907780 ↗
• MalfunctionDec 16, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED PROCEDURE, THE NURSE DISCOVERED A 1MM*1MM PIECE MISSING IN THE HEAD OF THE TWINFIX ANCHOR. UPON X-RAY FLUOROSCOPY, IT WAS NOT FOUND INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS RESUMED USING THE SAME DEVICE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23816425 ↗
• MalfunctionDec 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A ROTATOR-CUFF REPAIR SURGERY, ONE (1) TWINFIX ULTRA ANCHOR SPLIT. ALL THE PIECES WERE REMOVED FROM PATIENT WITH TWEEZERS AND SUCTION. THE PROCEDURE WAS RESUMED WITHOUT DELAY USING AN EQUIVALENT SN BACKUP ON THE ORIGINALLY DRILLED BONE HOLE OF 4.5MM, NO VOID WAS LEFT IN PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23804793 ↗
• MalfunctionDec 12, 2025Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A RIGHT SHOULDER ROTATOR CUFF LIGAMENT REPAIR, TWO (2) TWINFIX ANCHORS WERE FRACTURED AND CAME OUT. THE PIECES WERE REMOVED FROM PATIENT WITH TWEEZERS AND SUCTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT SN BACK-UP IN THE ORIGINALLY DRILLED BONE HOLE OF 4.5 MM, NO VOID WAS LEFT IN PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23788943 ↗
• InjuryDec 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED PROCEDURE, AFTER THE SURGEON FINISHED IMPLANTING THE TWINFIX ULTRA HA 4.5 W/2 UB (WH & BLUE, THE HEAD OF THE INSERTER DEVICE BROKE INSIDE THE PATIENT'S BODY, WITH A LENGTH OF APPROXIMATELY 5MM AND 2 PIECES. THE BROKEN PIECES WERE TOO SMALL TO BE FOUND UNDER FLUOROSCOPY; THERE IS POSSIBILITY OF FRAGMENTS RESIDUE INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED USING THE SAME DEVICE, AND IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23768202 ↗
• MalfunctionDec 2, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, TWO (2) TWINFIX ULTRA HA ANCHORS BROKE WHILE BEING IMPLANTED. ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT USING TWEEZERS AND GRASPERS. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT SN BACK-UP IN THE ORIGINALLY DRILLED BONE HOLE. THERE WAS A DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23700638 ↗
• MalfunctionDec 1, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, A SMALL IRON PIECE AT THE TOP OF THE TWINFIX ULTRA BROKE OFF AND FELL INTO THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A SN EQUIVALENT DEVICE. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23687199 ↗
• MalfunctionNov 21, 2025Break; Fracture; Material Twisted/Bent; Break; Fracture; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, A TWINFIX ULTRA HA 4.5 W/2 UB WH & BLUE WAS FRACTURED AND THE SUTURE WAS BROKEN. THE INSERTION SITE WAS CLEARED OF ALL DEBRIS PRIOR TO INSERTION, AND A 3.8MM BONE CONE WAS USED TO PREPARE THE INSERTION SITE. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK UP IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23622543 ↗
• MalfunctionNov 20, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY ONE TWINFIX ULTRA SUTURE ANCHOR BROKE INSIDE THE PATIENT; ALL PIECES WERE REMOVED USING TWEEZERS AND SUCTION WITH NO VOID LEFT. THE PATIENT¿S STATUS WAS REPORTED AS FINE. THE PROCEDURE WAS RESUMED WITHOUT ANY SURGICAL DELAY USING AN EQUIVALENT S+N BACKUP, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23611419 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K151105. One submission often covers many models, so check the product and lot details in each record.

• Z-0142-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX AB 5.0 SUTR ANCHR W/2 38 DURAB-Absorbable Suture anchors Product Number: 72200785
• Z-0166-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR CRVD 2.3 SA UB COBRD BLACK- Absorbable Suture anchor Product Number: 72203291
• Z-0151-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE -Absorbable Suture anchor Product Number: 72201994
• Z-0149-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK-Absorbable Suture anchor Product Number: 72201992
• Z-0144-2021 · Sep 9, 2020 · Open, Classified
  ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anchors Product Number: 72201494
• Z-0147-2021 · Sep 9, 2020 · Open, Classified
  RAPTORMITE 3.7MM AB W/ NEEDLES AND TWO-Absorbable Suture anchor Product Number: 72201805
• Z-0174-2021 · Sep 9, 2020 · Open, Classified
  MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204983
• Z-0145-2021 · Sep 9, 2020 · Open, Classified
  ULTRA FAST-FIX AB ASSEMBLY-REVERSE CURVE-Absorbable Suture anchor Product Number: 72201495
• Z-0137-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO- Absorbable Suture anchors Product Number: 7210710
• Z-0165-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE- Absorbable Suture anchor Product Number: 72203290
• Z-0175-2021 · Sep 9, 2020 · Open, Classified
  MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204984
• Z-0163-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202626
• Z-0150-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.3 W. UB COBRAID BLUE-Absorbable Suture anchor Product Number: 72201993
• Z-0159-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA PLLA HA 4.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202612
• Z-0161-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA PLLA HA 6.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202620

…and 25 more.