TEMA Elbow 9015.90.006Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08033390207935), received between Oct 3, 2024 and Sep 19, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2025Mechanical Problem; Mechanical Problem

  ELBOW REVISION SURGERY PERFORMED ON (B)(6)2025, DUE TO DISASSOCIATION OF COMPONENTS. HUMERAL BODY WITH SAFETY SCREW DISENGAGED FROM MODULAR SPACER. THIS REVISION IS REGISTERED AS INTERNAL COMPLAINT (B)(4) AND REPORTED TO THE FDA WITH MFR. 3008021110-2025-00115. DURING THE REVISION SURGERY, THE FOLLOWING DRIVER FOR 2NM TORQUE LIMITER USED FOR FINAL IMPLANT ASSEMBLY BROKE IN IMPLANTING THE NEW AXLE: SCREWDRIVER SHAFT FOR AXLE (PART CODE 9015.90.006, LOT NUMBER 24BQ0A7). MOREOVER, THE TIP OF A REVISION/CONVERSION AXLE EXTRACTOR DRIVER BROKE INSIDE THE AXLE PREVIOUSLY IMPLANTED WHILE TRYING TO IMPLANT NEW ONE: THIS EVENT IS REGISTERED AS INTERNAL COMPLAINT (B)(4) AND REPORTED TO THE FDA WITH MFR. 3008021110-2025-00117. WE DID NOT RECEIVE ANY ADDITIONAL INFORMATION ABOUT THE PATIENT. THE EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23094566 ↗
• MalfunctionAug 2, 2025Break; Break

  INTRA-OPERATIVE ISSUE OCCURRED DURING AN ELBOW SURGERY PERFORMED ON (B)(6) 2025. THE SURGEON TRIED LINKING IMPLANTS USING AXLE ON A TOTAL ELBOW ARTHROPLASTY AND TIP OF DRIVER BROKE INSIDE THE AXLE WHILE TRYING TO IMPLANT. NO BROKEN PIECES WERE LEFT IN THE PATIENT. THE INSTRUMENT INVOLVED IN THIS EVENT IS THE FOLLOWING: - SCREWDRIVER SHAFT FOR AXLE (PART CODE 9015.90.006, LOT NUMBER 23BQ096) THE EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22694126 ↗
• MalfunctionOct 15, 2024Break; Break

  DURING AN ELBOW SURGERY PERFORMED ON (B)(6) 2024, THE INSTRUMENT SCREWDRIVER SHAFT FOR AXLE (PART CODE 9015.90.006, LOT NUMBER 22BQ06Y) BROKE AFTER USING THE TORQUE LIMITING DRIVER TO INSERT THE AXLE. ACCORDING TO THE INFORMATION RECEIVED, THE TIP OF THE INSTRUMENT BROKE WHEN TIGHTENING THE AXLE. THE PATIENT IS A FEMALE, 78 YEARS OLD. THE EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20448962 ↗
• MalfunctionOct 3, 2024Break; Break

  INTRA-OPERATIVE ISSUE OCCURRED DURING AN ELBOW REVISION SURGERY PERFORMED ON (B)(6)2024. THE SCREWDRIVER SHAFT FOR AXLE (PART CODE 9015.90.006, LOT NUMBER 23BQ096) BROKE WHILE TRYING TO REMOVE THE AXLE. MIDAS CUTTING TOOL WAS USED TO CUT IMPLANT FOR REMOVAL. THE INSTRUMENT WAS USED FOR THE FIRST TIME. THE RELATED POST-OPERATIVE ISSUE WAS REGISTERED AS INTERNAL COMPLAINT (B)(4) AND REPORTED TO THE FDA WITH MFR 3008021110-2024-00073. EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20358667 ↗