T-FIX 014771Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010446114), received between Mar 27, 2018 and Nov 17, 2025 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (7 reports).

1 other recall cover devices cleared under the same FDA submission (K925573); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE, WHILE DRILLING INTO THE GLENOID THROUGH THE GUIDE, THE INNER DRILL OF THE T-FIX RCG STERILE PAC WAS BROKEN. ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569519 ↗
• MalfunctionOct 22, 2025Break; Break

  IT WAS REPORTED THAT, DURING A SURGERY, THE WING AT THE TIP OF ONE (1) T-FIX DRILL TIP DISINTEGRATED, BROKE OFF IN THE PATIENT UPON OPENING. THE PROCEDURE WAS RESUMED, AFTER A 10 TO 15-MINUTE DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23356131 ↗
• MalfunctionJan 28, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE T-FIX RCG PACKING WAS NOT SEALED WELL. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY, IF THERE WAS PATIENT INVOLVEMENT. HOWEVER, THERE WAS NO SURGICAL DELAY AND A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21260906 ↗
• MalfunctionJun 14, 2024Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC LATARJET SURGERY, WHEN DRILLING A BONE HOLE BY THE GLENOID FOSSA, THE PART OF THE T-FIX THAT CONNECTS TO THE OUTER DRILL CAME OFF AND THE DEVICE COULD NO LONGER BE CONNECTED TO THE OUTER DRILL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF 10 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19542026 ↗
• InjuryApr 11, 2024Break; Break

  IT WAS REPORTED THAT DURING A MINI-OPEN LATERJET PROCEDURE, THE SLEEVE OF THE 2.0MM T-FIX DRILL BROKE WHEN DRILLING THE INFERIOR HOLE USING WITH A GLENOID GUIDE. THE METAL SLEEVE BROKE OFF ABOUT 1 INCH INSIDE THE GLENOID. THE PIECES WERE REMOVED FROM THE PATIENT. THERE WAS A DELAY IN THE LESS THAN 30 MINUTES AND IT WAS COMPLETED WITH A COMPETITOR DEVICE ( SMALL AND LARGE FRAG SCREW SET, SYNTHES) USING AN ADDITIONAL BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 19094127 ↗
• InjuryJun 16, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC BONE BLOCK SURGERY, WHEN TRYING TO DRILL THE ¿RIGHT¿ BULLET FROM THE JIG, RESISTANCE WAS FELT WHEN DRILLING. IT WAS NOTICED THAT A SMALL FRAGMENT OF THE DRILL SLEEVE WAS STUCK IN THE BULLET. THE BULLET WAS REMOVED AND REMNANT OF THE SLEEVE REMOVED FROM THE BULLET. A SECOND PACK WAS OPENED AND USED TO CHECK IF THE NEW SLEEVE WOULD PASS SAFELY THROUGH THE RIGHT BULLET, THE RIGHT TUNNEL WAS SUCCESSFULLY DRILLED WITH THE BACKUP PACK. A DELAY OF 3 MINUTES WAS REPORTED AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12010336 ↗
• MalfunctionFeb 13, 2019Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE WHILE USING THE DRILL AND SLEEVE TO DRILL THROUGH THE GLENOID BONE IN THE SHOULDER VIA THE GLENOID DRILLING GUIDE THE DRILL OF THE PRODUCT BROKE OF IN THE BONE. THE FLUTED ENDS WERE EXPOSED BUT THE DRILL WAS STILL PARTLY IN THE GLENOID. A GRASPER WAS USED TO PULL THE DRILL OUT OF THE BONE AND REMOVED FROM THE PATIENT. A NEW DRILL AND SLEEVE WAS OPENED AND THE PROCEDURE CONTINUED WITH ONLY A FEW MINUTES DELAY (3MINS). ALL THE DRILL PARTS WERE REMOVED. A BACK UP DEVICE WAS AVAILABLE AND NO PATIENT INJURIES OR SIGNIFICANT DELAY WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8336732 ↗
• MalfunctionJan 24, 2019Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC LATERJET, WHILE USING THE DRILL AND SLEEVE TO DRILL THROUGH THE GLENOID BONE IN THE SHOULDER VIA THE GLENOID DRILLING GUIDE THE DRILL OF THE PRODUCT BROKE OF IN THE BONE. THE FLUTED ENDS WERE EXPOSED BUT THE DRILL WAS STILL PARTLY IN THE GLENOID. A GRASPER WAS USED TO PULL THE DRILL OUT OF THE BONE AND REMOVED FROM THE PATIENT. A NEW DRILL AND SLEEVE WAS OPENED AND THE PROCEDURE CONTINUED WITH ONLY A FEW MINUTES DELAY (3MINS). I RETRIEVED THE DRILL PARTS TO BE ANALYSED.

  Patient problems: Foreign Body In Patient

  MAUDE report 8274634 ↗
• MalfunctionMar 27, 2018Break

  IT WAS REPORTED THAT THE T-FIX WAS READY TO BE USED, PLUGGED ON THE POWER TOOL. THE T-FIX BROKE AT FULL SPEED, ENTERING THE CORACOID PROCESS. THE TIP OF THE MALE PART BROKE, JUST UNDER THE CONNECTION OF MALE/FEMALE PARTS. BROKEN PIECE WAS REMOVED FROM THE PATIENT. PROCEDURE WAS COMPLETED WITH A BACK-UP DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7376039 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K925573. One submission often covers many models, so check the product and lot details in each record.

• Z-2702-2020 · Jun 24, 2020 · Open, Classified
  Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves - Product Usage: indicated for use in surgical arthroscopic rotator cuff repair procedures. REF/ Catalog Number : 0147