FAST-FIX 72203986Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885554032154), received between Mar 26, 2018 and Aug 25, 2025 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K132079); 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE T2 OF THE FAST FIX DID NOT DEPLOYED WHEN THE TRIGGER WAS PUSHED. T1 WAS DEPLOYED WITH NO ISSUES. ALL ANCHORS WERE REMOVED USING FORCEPS THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22890206 ↗
• InjuryDec 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN ARTHROSCOPY WITH TFCC FAST-FIX KIT, THE PATIENT HAD STIFFNESS OF RIGHT DIGITS 2-4 PIP JOINTS ON (B)(6) OF 2019 . THE EVENT WAS TREATED WITH MANIPULATION UNDER ANESTHESIA. THE OUTCOME OF THE PATIENT IS RESOLVED.

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 12951832 ↗
• InjurySep 9, 2021Break; Break

  IT WAS REPORTED THAT, AFTER ARTHROSCOPY, A TFCC FAST FIX KIT HAS A FIBER WIRE GRINDING OVER DISTAL ULNAR AND RIGHT WRIST DURING MOTION. PROCEDURE HAD BEEN COMPLETED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: Foreign Body In Patient

  MAUDE report 12451573 ↗
• MalfunctionMar 22, 2019Premature Activation; Retraction Problem

  IT WAS REPORTED THAT DURING A WRIST SURGERY AFTER T1 WAS DEPLOYED, THE INTERNAL ROD DID NOT RETRACT, CAUSING A SIMULTANEOUS DEPLOYMENT. AN OPEN SURGERY WAS PERFORMED TO RETRIEVE T2 AND THE SUTURE MATERIAL WAS REMOVED FROM THE JOINT SPACE. NO SIGNIFICANT DELAY WAS REPORTED. A BACK UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8445720 ↗
• InjuryFeb 28, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT RE-INJURED THE WRIST AND HAD A SURGICAL INTERVENTION.

  Patient problems: Injury

  MAUDE report 8377473 ↗
• InjuryFeb 14, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A LEFT ELBOW DISLOCATION THAT WAS TREATED WITH ULNAR NERVE RELEASE. PATIENT WAS RECOVERED.

  Patient problems: Bone Fracture(s)

  MAUDE report 8340748 ↗
• MalfunctionMar 26, 2018Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE SECOND ANCHOR PRE-DEPLOYED DURING THE SURGERY. 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 7372178 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K132079. One submission often covers many models, so check the product and lot details in each record.

• Z-1822-2015 · Apr 30, 2015 · Terminated
  ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intended for Meniscal Repair.