NA 71364006Recalls & reported problems

Summary

The FDA's MAUDE database contains 197 adverse event reports that list this exact device (DI 03596010199225), received between Aug 23, 2017 and Jun 10, 2026 — classified as 19 injuries, 178 malfunctions.

The most frequently reported specific device problem is “Break” (135 reports).

2 other recalls cover devices cleared under the same FDA submission (K123598); 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 25 most recent of 197 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2026Fracture

  IT WAS REPORTED THAT, DURING A THA SURGERY, ONE (1) T- HANDLE WAS BROKEN INTO TWO PIECES. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25462298 ↗
• MalfunctionApr 17, 2026Break

  IT WAS REPORTED THAT, DURING A THA REVISION SURGERY (UNKNOWN IF FROM S+N IMPLANTS), THE CONNECTION PARTS IN TWO (2) T-HANDLE WERE BROKEN. 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 24913680 ↗
• MalfunctionJan 23, 2026Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE HANDLE OF ONE (1) T-HANDLE BROKE. AFTER THE PATIENT¿S FEMORAL HEAD WAS REMOVED, THE SCREW WAS INSERTED INTO THE HEAD AND TIGHTENED WITH FORCE, AND WHILE APPLYING TORQUE, THE HANDLE OF THE DEVICE FRACTURED INTO TWO PIECES. NO BROKEN PIECES FELL INSIDE THE PATIENT. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24171480 ↗
• MalfunctionDec 3, 2025Break; Fracture; Material Deformation; Break; Fracture; Material Deformation

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE CONNECTION PART OF A T-HANDLE WAS DEFORMED AND BROKEN WHILE IN NORMAL USE. THE PROCEDURE WAS RESUMED, AFTER A NON SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23704738 ↗
• MalfunctionDec 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THA SURGERY, A T-HANDLE BROKE. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23703793 ↗
• MalfunctionNov 30, 2025Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE CONNECTION PART OF A T-HANDLE WAS DEFORMED AND BROKEN WHILE IN NORMAL USE. THE PROCEDURE WAS RESUMED, AFTER A NON SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23677074 ↗
• MalfunctionOct 21, 2025Break; Break

  IT WAS REPORTED THAT DURING A THR SURGERY, THE T-HANDLE BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23353548 ↗
• MalfunctionSep 16, 2025Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) T-HANDLE BROKE WHILE HAND REAMING. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THIS CAUSED ANY DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23069099 ↗
• MalfunctionSep 9, 2025Crack; Fracture; Crack; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) T-HANDLE BROKE WHILE THE SURGEON WAS TRYING TO REAM THE IM CANAL. NO BROKEN PIECES WERE LEFT IN THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23011609 ↗
• MalfunctionSep 7, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY, THE PRONGS AT THE END OF THE T-HANDLE BROKE WHEN TWISTING THE REAMER. NOTHING FELL IN THE INCISION AND THE PIECE THAT BROKE WAS HANDLED BY THE SURGEON. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22989504 ↗
• MalfunctionJun 21, 2025Break; Break

  IT WAS REPORTED THAT, DURING THR SURGERY, ONE (1) T-HANDLE WAS BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22303890 ↗
• MalfunctionJun 12, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR, ONE (1) T-HANDLE WAS DAMAGED (FRACTURE) DURING FEMORAL REAMING. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22199657 ↗
• MalfunctionJun 9, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR REVISION SURGERY, THE T-HANDLE BROKE AT THE FRONT. THEN, IT HAD TO CONTINUE USING A DRILL. NO PIECES FELL INSIDE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A COMPETITOR DEVICE (DEPUY/SYNTHES). PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22171977 ↗
• MalfunctionDec 12, 2024Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY A T-HANDLE WAS BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20914118 ↗
• MalfunctionNov 29, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY, THE T-HANDLE BROKE WHILE REMOVING A 300 X 18MM REDAPT DISTAL REAMER. NOTHING WAS LEFT OR FELL IN THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20808876 ↗
• MalfunctionOct 14, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY, THE T-HANDLE BROKE WHEN IT WAS TWISTED WITH BOTH HANDS. ALL PIECES WERE RECOVERED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20447028 ↗
• MalfunctionAug 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, A T-HANDLE BROKE OFF WHEN IT WAS HIT WITH A HAMMER. NO PIECE FELL INSIDE THE PATIENT. THE SURGERY WAS RESUMED USING S+N BACKUP DEVICE, AFTER A NON-SIGNIFICANT DELAY. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19961937 ↗
• MalfunctionAug 2, 2024Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE LOCKING MECHANISM OF A T-HANDLE BROKE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19893367 ↗
• MalfunctionJun 17, 2024Break; Break

  IT WAS REPORTED THAT, DURING THR SURGERY, THE TIP OF ONE (1) T-HANDLE BROKE WHILE REAMING. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED, AND IF THERE WAS ANY SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19554964 ↗
• MalfunctionJun 17, 2024Break; Break

  IT WAS REPORTED THAT, DURING HEMI HIP SURGERY, THE T-HANDLE BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19554243 ↗
• MalfunctionMay 30, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, ONE (1) T-HANDLE HAD ITS CONNECTING-END BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19431340 ↗
• InjuryMay 7, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY, THE T- HANDLE 71364006 ON THE REDAPT HIP KIT BROKE UNDER TENSION IN TRYING TO REAM THE FEMUR, VERY DIFFICULT BONE, TO REAM DUE TO PATIENT CONDITION. THE REAMER HAD JAMMED INTO THE FEMUR AND HANDLE BROKE DUE TO IT TRYING TO RETRIEVE THE JAMMED REAMER, SURGEON HAD TO USE SLAP HAMMER TO GET THE REAMER OUT. NO PIECES OF THE HAND PIECE ENTERED THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, BUT IT IS UNKNOWN HOW. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: Laceration(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 19261084 ↗
• MalfunctionMar 6, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) T-HANDLE BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18852330 ↗
• MalfunctionFeb 13, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, THE PLASTIC T-HANDLE BROKE AWAY FROM THE STEEL. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18693185 ↗
• MalfunctionFeb 8, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, A T-HANDLE FRACTURED AT THE CAPTURE MECHANISM DURING USE WITH A DISTAL DRILL. ALL THE PIECES OF THE HANDLE WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18672794 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123598. One submission often covers many models, so check the product and lot details in each record.

• Z-0730-2019 · Jan 7, 2019 · Terminated
  SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
• Z-1008-2017 · Nov 16, 2016 · Terminated
  REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116