Arthrex® AR-9545-T15HRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867225091), received between Dec 4, 2023 and Jun 19, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 05/23/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06577204 THAT AN AR-9545-T15-01 DRIVER SHAFT AND AN AR-9545-T15H TORQUE INDICATING ADAPTER WERE UNABLE TO BE TAKEN APART. THIS OCCURRED AFTER USE IN AN RTSA PROCEDURE WITH NO EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19568018 ↗
• MalfunctionJun 6, 2024Break; Break

  ON 5/9/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06563758 THAT AN AR-9545-T15H TORQUE INDICATING ADAPTER BROKE AND, THEREFORE, CAUSED THE AR-9545-T15-01 DRIVER SHAFT TO TORQUE OUT. THEY HAD A SECOND SET OF TRAYS AVAILABLE AND COMPLETED THE CASE WITHOUT HARM. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19477609 ↗
• MalfunctionFeb 16, 2024Break; Break

  ON 01/30/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9545-T15H TORQUE INDICATING ADAPTER BROKE. THIS OCCURRED DURING A REVERS TOTAL SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2024 WHEN THE TORQUE INDICATOR BROKE WHEN APPROACHING 5. THE CASE WAS COMPLETED SUCCESSFULLY. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.

  Patient problems: Insufficient Information

  MAUDE report 18725990 ↗
• MalfunctionDec 19, 2023Defective Device; Defective Device

  ON 11/20/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9545-T15H TORQUE INDICATING ADAPTER MALFUNCTIONED DURING USE. THE CASE WAS COMPLETED SUCCESSFULLY, WITH NO FURTHER INFORMATION PROVIDED. THIS WAS DISCOVERED DURING A REVERSE TSA PROCEDURE ON 11/14/2023, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18359461 ↗
• MalfunctionDec 4, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 11/7/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS- (B)(4) THAT AN AR-1999HH RATCHETING HANDLE, HYBRID HUDSON, AND AN AR-9545-T15H TORQUE INDICATING ADAPTOR HAD AN ISSUE. WHILE INSPECTING THE AR-1999HH RATCHETING HANDLE INSIDE THE WAREHOUSE, IT WAS DISCOVERED THAT THE INSTRUMENT APPEARS TO BE JAMMED AND HAS DIFFICULTY DISENGAGING FROM THE AR-9545-T15H TORQUE INDICATING ADAPTOR. THIS ISSUE CONTINUED AFTER FURTHER TESTING IN THE WAREHOUSE, AND THE DEVICES ARE NO LONGER OPERATIONAL. THIS WAS DISCOVERED DURING INSPECTION, WITH NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18258180 ↗