RELIANCE LITe 48061000Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 07613327263671), received between Apr 26, 2016 and May 15, 2026 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Fracture” (20 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2026Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT THE SECURING MECHANISM OF A RELIANCE LITE T-HANDLE QUICK CONNECT FRACTURED INTRA-OPERATIVELY. IT IS CURRENTLY UNKNOWN IF THE FRACTURED COMPONENT CAME INTO CONTACT WITH THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25184911 ↗
• MalfunctionFeb 24, 2026Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT THE HANDLE ATTACHMENTS OF TWO RELIANCE LITE T- HANDLES FRACTURED INTRA-OPERATIVELY. IT WAS FURTHER REPORTED THAT THE FRACTURED COMPONENT ENTERED THE PATIENT WOUND SITE AND WAS SUBSEQUENTLY RETRIEVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE SECOND OF TWO HANDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24434250 ↗
• MalfunctionFeb 24, 2026Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT THE HANDLE ATTACHMENTS OF TWO RELIANCE LITE T- HANDLES FRACTURED INTRA-OPERATIVELY. IT WAS FURTHER REPORTED THAT THE FRACTURED COMPONENT ENTERED THE PATIENT WOUND SITE AND WAS SUBSEQUENTLY RETRIEVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE FIRST OF TWO HANDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24434247 ↗
• MalfunctionSep 9, 2025Fracture; Fracture

  A CUSTOMER REPORTED THAT A FRAGMENT FROM A RELIANCE LITE T- HANDLE, QUICK CONNECT FRACTURED OFF INTRA-OPERATIVELY. THE FRAGMENT WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23001492 ↗
• MalfunctionMay 15, 2025Fracture; Fracture

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22031875 ↗
• MalfunctionAug 1, 2022Fracture; Mechanical Problem; Fracture; Mechanical Problem

  IT WAS REPORTED THAT TWO (2) RELIANCE LITE T- HANDLES WERE UNABLE TO BE USED INTRA-OPERATIVELY; THEY NO LONGER CONNECT TO THE SHAVERS. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO ADVERSE CONSEQUENCES, SURGICAL DELAY OR MEDICAL INTERVENTION WERE REPORTED. THIS REPORT CAPTURES THE FIRST HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15139512 ↗
• MalfunctionAug 1, 2022Mechanical Problem; Mechanical Jam; Mechanical Problem; Mechanical Jam

  IT WAS REPORTED THAT TWO RELIANCE LITE T- HANDLES WERE UNABLE TO BE USED INTRA-OPERATIVELY; THEY NO LONGER CONNECT TO THE SHAVERS. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO ADVERSE CONSEQUENCES, SURGICAL DELAY OR MEDICAL INTERVENTION WERE REPORTED. THIS REPORT CAPTURES THE SECOND HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15139479 ↗
• MalfunctionJul 27, 2022Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT A RELIANCE LITE T HANDLE BROKE INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15115980 ↗
• MalfunctionJun 1, 2022Fracture; Mechanical Jam; Fracture; Mechanical Jam

  IT WAS REPORTED THAT A RELIANCE T-HANDLE WAS JAMMING OUTSIDE THE OPERATING ROOM. THERE WAS NO ASSOCIATED PROCEDURE WITH THIS EVENT, THEREFORE, NO ADVERSE CONSEQUENCES TO ANY PATIENTS WERE SEEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14566795 ↗
• MalfunctionMar 8, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A RELIANCE T-HANDLE IS HAVING TROUBLE RELEASING SHAFTS OUTSIDE THE OR. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13697286 ↗
• MalfunctionMar 21, 2018Fracture; Break; Fracture

  IT WAS REPORTED THE INNER SHAFT OF THE HANDLE BROKE WHILE DISTRACTING THE DISC SPACE. THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7358009 ↗
• MalfunctionJan 29, 2018Fracture; Material Fragmentation; Fracture

  IT WAS REPORTED THAT THE QUICK RELEASE HANDLES BROKE DURING SURGERY. ALL THE BROKEN FRAGMENTS WERE RETRIEVED. NO ADVERSE HEALTH CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7224298 ↗
• MalfunctionNov 22, 2017Break; Fracture; Fracture

  IT WAS REPORTED THAT; WHILE USING THE SHAVERS IN THE DISC SPACE, THE INNER TABS ON BLUE T HANDLE BROKE ON BOTH T HANDLES IN THE RELIANCE LITE INSTRUMENTS SET.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7052228 ↗
• MalfunctionNov 22, 2017Break; Fracture; Fracture

  IT WAS REPORTED THAT; WHILE USING THE SHAVERS IN THE DISC SPACE, THE INNER TABS ON BLUE T HANDLE BROKE ON BOTH T HANDLES IN THE RELIANCE LITE INSTRUMENTS SET

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7052221 ↗
• MalfunctionNov 21, 2017Break; Fracture; Fracture

  IT WAS REPORTED THAT; DURING A LATERAL CASE, TWO SEPARATE TRIAL/SHAVER HANDLES BROKE, HALF THE QUICK RELEASE MECHANISM FELL ONTO THE FIELD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7050037 ↗
• MalfunctionJul 27, 2017Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT; DOCTOR WAS TURNING A SHAVER IN A DISC SPACE WHEN A HANDLE BROKE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6746566 ↗
• MalfunctionApr 17, 2017Break; Detachment Of Device Component; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT; UPON IMPACTING THE HANDLE, A PIECE OF METAL BROKE OFF THE BOTTOM OF T HANDLE. THE PIECE WAS RETRIEVED IMMEDIATELY. THE SURGEON THEN USED THE SLAP HAMMER TO REMOVE THE TRAIL, STILL ATTACHED TO THE T HANDLE, AND UPON I,PARTING THE HAMMER ON THE HANDLE, THE BLUE T PART OF THE HANDLE REMOVED, STILL LEAVING THE TRIAL IN PLACE. THE SLAP HAMMER WAS REATTACHED TO THE TRIAL AND SUCCESSFULLY REMOVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6498756 ↗
• MalfunctionNov 15, 2016Break

  IT WAS REPORTED THAT; HANDLE BROKE WHILE TRIALING

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6104750 ↗
• MalfunctionNov 15, 2016Fracture; Break; Fracture

  IT WAS REPORTED THAT; HANDLE BROKE WHILE TRIALING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6104714 ↗
• MalfunctionOct 10, 2016Break; Detachment Of Device Component

  A SHAVER TURNED WITHIN THE T HANDLE BREAKING A PART SOME OF THE INSIDE OF THE T HANDLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6015464 ↗
• MalfunctionAug 24, 2016Break; Fracture; Fracture

  IT WAS REPORTED THAT THE HANDLE BROKE WHEN TAKE WAS REMOVING FROM TRIAL

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5901406 ↗
• MalfunctionMay 25, 2016Break; Fracture; Fracture

  IT WAS REPORTED THAT THE SURGEON WAS USING T-HANDLE WITH TRIAL ATTACHMENT IN DISC SPACE, HE THEN BEGAN TO REMOVE THE TRIAL WHEN HE FELT SOMETHING "GIVE WAY" OR BREAK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5679819 ↗
• MalfunctionApr 26, 2016Break; Fracture; Fracture

  IT WAS REPORTED THAT TWO T HANDLES BROKE. DOCTOR WAS TRYING TO DISTRACT VERY TIGHT DISC SPACE AND THE TWO T HANDLES BROKE. USED ANOTHER T HANDLE FROM A BACKUP TRAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5607704 ↗
• MalfunctionApr 26, 2016Break; Fracture; Fracture

  IT WAS REPORTED THAT TWO T HANDLES BROKE. DOCTOR WAS TRYING TO DISTRACT VERY TIGHT DISC SPACE AND THE TWO T HANDLES BROKE. USED ANOTHER T HANDLE FROM A BACKUP TRAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5607430 ↗