TIBIAL INSERTION GUIDE, SUPRAPATELLAR 1255-300Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00848665039153), received between Dec 21, 2021 and Nov 4, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (6 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. 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 4, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 10/10/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN 1255-300 INSERTION GUIDE, THE BOLT THAT ATTACHES TO THE GIG THE BOLT AND JIG CROSS THREADED TOGETHER AND GOT STUCK, BROKE THE SCREWDRIVER BECAUSE IT WAS TIGHT. NOTICED DURING A CASE AND SWAPPED WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23464541 ↗
• MalfunctionJun 18, 2025Break; Break

  ON 05/27/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN 0837-000 IMPACTOR PAD CONNECTION PORTION OF THE STRIKE PLATE BROKE IN THE CONNECTION PORTION OF THE 1255-300 SUPRAPATELLAR INSERTION GUIDE. A CASE WAS INVOLVED, AND NO PATIENT WAS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22285262 ↗
• MalfunctionJan 6, 2025Break; Break

  ADDITIONAL INFORMATION: REP STATED LOCKING KNOB WAS ALSO STUCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21085150 ↗
• MalfunctionDec 15, 2023Loose or Intermittent Connection; Detachment of Device or Device Component; Loose or Intermittent Connection; Detachment of Device or Device Component

  ON 11/16/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06403211 THAT A 1255-300 TIBIAL INSERTION GUIDES METAL JIG WHERE THE NAIL CONNECTS CAME LOOSE (SOUNDS LIKE THE SPOT WIELDS BROKE), AND THE NAIL WOULD SPIN AND NOT LINE UP WITH THE JIG. THE 1239-100 INSERTION GUIDE WAS STRIPPED AND WOULD NOT COME OUT OF THE 1255-300. THIS OCCURRED DURING A CASE WITH NO EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18340877 ↗
• MalfunctionOct 24, 2023Break; Break

  ON 1/15/2024, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING INFORMATION VIA EMAIL: THE PROCEDURE WAS COMPLETED BY THE SURGEON MANUALLY INSERTING THE SCREWS PROXIMALLY INSTEAD OF THROUGH THE JIG. THERE WAS NO CASE DELAY REPORTED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE FIRST INCIDENT HAD PREVIOUSLY BEEN REPORTED TO ARTHREX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17996270 ↗
• MalfunctionJul 28, 2023Break; Break

  ON (B)(6)2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A 1255-300 SUPRAPATELLAR INSERTION GUIDE AND A 1239-100 LOCKING KNOB INSERTION GUIDE HAD AN ISSUE. DURING A CASE ON (B)(6)/2023, AFTER THE NAIL WAS INSERTED AND UPON TRYING TO ROTATE THE NAIL VIA JIG, THE SURGEON NOTICED THAT THE NAIL WASN'T MOVING WITH JIG MOVEMENT. AFTER FURTHER EXAMINATION, HE NOTICED THE JIG ARM HAD BEEN SNAPPED OFF. THE CASE CONTINUED WITH LOCKING THE NAIL DISTALLY, THEY HAD TO IMPROVISE BY PERFORMING PERFECT CIRCLES PROXIMALLY THROUGH THE JIG BEING BROKEN. NO CASE/PATIENT INVOLVEMENT. THIS OCCURRED DURING USE WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON (B)(6)2023, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING INFORMATION VIA EMAIL: THIS OCCURRED DURING A TIBIAL NAIL PROCEDURE. A PIECE OF THE INSTRUMENT BROKE OFF INSIDE THE PATIENT, AND ALL FRAGMENTS WERE RETRIEVED. THE CASE WAS COMPLETED SUCCESSFULLY, BUT THE CASE WAS DELAYED FOR 35 MINUTES. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON (B)(6)2023, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING INFORMATION VIA EMAIL: ONLY THE 1255-300 SUPRAPATELLAR INSERTION GUIDE BROKE OFF INSIDE THE PATIENT AND WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17419535 ↗
• MalfunctionMay 22, 2023Break; Material Fragmentation; Break; Material Fragmentation

  ON 04/26/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A 1255-300 TIBIAL INSERTION GUIDE BROKE. THIS OCCURRED DURING A TIBIA IMN ON (B)(6) 2023, THE TULIP HANDLE WAS BEING HIT WITH A MALLET TO BACKSLAP THE IMPLANT AFTER THE DISTAL INTERLOCK SCREWS WERE PLACED IN ORDER TO REDUCE THE MID-SHAFT TIBIAL FRACTURE. AFTER A FEW TAPS THE JIG DISLODGED. THE CASE WAS COMPLETED UTILIZING PERFECT CIRCLES IN THE PROXIMAL PORTION OF THE NAIL. THE FRAGMENT WAS RETRIEVED, AND NOTHING WAS LEFT IN THE PATIENT WHICH WAS VERIFIED THROUGH X-RAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16973072 ↗
• MalfunctionFeb 20, 2023Break

  IT WAS REPORTED ON 01/30/2023 BY A SALES REPRESENTATIVE VIA SEMS THAT AN 1255-300 INSERTION GUIDE BROKE. CASE INVOLVEMENT, DEVICE BROKE DURING USE. CASE COMPLETED WITH NO ISSUES.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16403919 ↗
• MalfunctionDec 21, 2021Mechanical Problem; Difficult to Remove; Physical Resistance/Sticking

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN 1239-100 LOCKING KNOB CROSS-THREADED INTO AN 1255-300 SUPRAPATELLAR GUIDE. THIS WAS DISCOVERED DURING A TIBIAL NAIL PROCEDURE. SURGEON COULD NOT COMPLETE CASE DUE TO THE DEVICES GETTING STUCK. ABOUT AN HOUR OR SO AFTER THE CASE, SALES REPRESENTATIVE WAS FINALLY ABLE TO REMOVE THE KNOB FROM THE GUIDE BUT THEY WERE BOTH UNSALVAGEABLE DUE TO THE CROSS-THREADING.

  Patient problems: Insufficient Information

  MAUDE report 13054589 ↗