FAST-FIX 72201495Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 03596010597236), received between Jul 29, 2019 and Dec 8, 2024 — classified as 8 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (12 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE T2 OF THE ULTRA FAST-FIX DID NOT TRIGGER. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20875397 ↗
• MalfunctionDec 8, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE ULTRA FAST-FIX T2 DID NOT TRIGGER. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE. THERE WAS A DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20875240 ↗
• MalfunctionOct 4, 2023Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A MENISCAL REPAIR SURGERY, TWO (2) ULTRA FAST-FIX T2 ANCHORS COULD NOT BE RELEASED IN THE MENISCUS AND THUS THE ENTIRE SYSTEM WAS REMOVED WITH GRASPING FORCEPS. SURGERY RESUMED AFTER A NON-SIGNIFICANT DELAY WITH A BACK-UP ULTRA FAST-FIX. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17869757 ↗
• InjuryNov 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON REGISTRY REVIEW 2021 NEW ZEALAND ACL REGISTRY IMPLANT REPORT, AN UNKNOWN AMOUNT OF PATIENTS REQUIRED A REVISION SURGERY AFTER AN ACL PROCEDURE USING THREE(3) ULTRAFASTFIX DEVICES. IT IS UNKNOWN HOW WERE THE EVENTS REATED/RESOLVED. PATIENTS OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 15874662 ↗
• InjuryAug 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON A CLINICAL EVALUATION REPORT (CER) IN THE NEW ZEALAND ACL REGISTRY, 3 PATIENTS HAD ARTHROFIBROSIS AFTER AN ACL PROCEDURE USING AN ULTRA FAST-FIX AB ASSEMBLY - REV CURVE. THE PATIENT OUTCOME IS UNKNOWN. THE INFORMATION PROVIDED IS ANONYMIZED; THEREFORE, ADDITIONAL INFORMATION IS NOT KNOWN AND IT IS NOT POSSIBLE TO COLLECT IT.

  Patient problems: Insufficient Information

  MAUDE report 15279785 ↗
• InjurySep 27, 2021Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, T2 ANCHOR OF ULTRA FAST-FIX DEVICE WAS NOT TRIGGERED. T1 WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12538074 ↗
• InjurySep 27, 2021Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, T2 ANCHOR OF ULTRA FAST-FIX DEVICE WAS NOT TRIGGERED. T1 WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12538071 ↗
• InjurySep 27, 2021Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, T2 ANCHOR OF ULTRA FAST-FIX DEVICE WAS NOT TRIGGERED. T1 WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12538066 ↗
• InjurySep 27, 2021Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, T2 ANCHOR OF ULTRA FAST-FIX DEVICE WAS NOT TRIGGERED. T1 WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12538065 ↗
• MalfunctionMar 11, 2021Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING THE SURGERY THE FAST FIX T2 DID NOT TRIGGERED. NO OTHER COMPLICATIONS WERE REPORTED. SMITH AND NEPHEW BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. UNKNOWN IF THERE WAS A DELAY. 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 11466807 ↗
• InjuryMar 11, 2021Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING THE SURGERY THE FAST FIX T2 DID NOT TRIGGERED. NO OTHER COMPLICATIONS WERE REPORTED. SMITH AND NEPHEW BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. UNKNOWN IF THERE WAS A DELAY. 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 11466788 ↗
• InjuryMar 11, 2021Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING THE SURGERY THE FAST FIX T2 DID NOT TRIGGERED. NO OTHER COMPLICATIONS WERE REPORTED. SMITH AND NEPHEW BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. UNKNOWN IF THERE WAS A DELAY. 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 11466772 ↗
• MalfunctionJan 10, 2020Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING SURGERY ULTRA FAST FIX T2 IMPLANT DID NOT DEPLOY. 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 9577994 ↗
• MalfunctionOct 17, 2019Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A SURGERY THE T2 WAS NOT TRIGGERING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE, IT IS UNKNOWN IF THERE WAS A SIGNIFICANT DELAY. 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 9205638 ↗
• MalfunctionOct 17, 2019Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A SURGERY THE T2 WAS NOT TRIGGERING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE, IT IS UNKNOWN IF THERE WAS A SIGNIFICANT DELAY. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. TASK COMPLETED. 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 9205617 ↗
• MalfunctionJul 29, 2019Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING THE SURGERY, T2 DID NOT TRIGGER. A BACKUP DEVICE WAS USED TO COMPLETE THE SURGERY. NO DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8838676 ↗
• MalfunctionJul 29, 2019Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING THE SURGERY, T2 DID NOT TRIGGER. A BACKUP DEVICE WAS USED TO COMPLETE THE SURGERY. NO DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8838433 ↗

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-0175-2021 · Sep 9, 2020 · Open, Classified
  MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204984
• Z-0171-2021 · Sep 9, 2020 · Open, Classified
  HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK- Absorbable Suture anchor Product Number: 72203707
• Z-0164-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA HA 6.5 W/2 UB (BLUE & BLK)- Absorbable Suture anchor Product Number: 72202631
• Z-0138-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX 5.0MM AB SUTURE ANCHOR-Absorbable Suture anchors Product Number: 7210711
• Z-0155-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/BL--Absorbable Suture anchor Product Number: 72202602
• Z-0172-2021 · Sep 9, 2020 · Open, Classified
  HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK- Absorbable Suture anchor Product Number: 72203708
• Z-0153-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.9 W. 2 UB WHITE / BLACK -Absorbable Suture anchor Product Number: 72201996
• Z-0148-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.3 W 1UB II BLUE-Absorbable Suture anchor Product Number: 72201991
• Z-0152-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE -Absorbable Suture anchor Product Number: 72201995
• Z-0141-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX AB 5.0 SUTR ANCHR W/2 38 ULTRA-Absorbable Suture anchors Product Number:72200777
• Z-0149-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK-Absorbable Suture anchor Product Number: 72201992
• Z-0158-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA PLLA/HA 6.5 W/3 UB- Absorbable Suture anchor Product Number: 72202610
• Z-0169-2021 · Sep 9, 2020 · Open, Classified
  HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK-- Absorbable Suture anchor Product Number: 72203705
• Z-0151-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE -Absorbable Suture anchor Product Number: 72201994
• Z-0145-2021 · Sep 9, 2020 · Open, Classified
  ULTRA FAST-FIX AB ASSEMBLY-REVERSE CURVE-Absorbable Suture anchor Product Number: 72201495

…and 25 more.