Arthrex® AR-9545-T15-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00888867225183), received between Jan 16, 2019 and Dec 1, 2025 — classified as 3 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 11/07/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9545-T15-01 DRIVER SHAFT TORQUE DRIVER BROKE AWAY AND HAD BAD BEARINGS. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23681413 ↗
• MalfunctionOct 16, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  ON 10/06/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9545-T15-01 T-15 SHORT DRIVE SHAFT TWISTED AND BROKE DURING A CASE. NO PATIENT WAS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23312114 ↗
• MalfunctionMay 1, 2025Material Twisted/Bent; Material Twisted/Bent

  ON 04/15/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9545-T15-01 DRIVER SHAFT HEAD WAS TWISTED AND DID NOT ENGAGE PROPERLY. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21941636 ↗
• MalfunctionMar 18, 2025Material Twisted/Bent; Material Twisted/Bent

  ON 03/03/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT A (QTY. 2) OF AN AR-9545-T15-01 DRIVER SHAFT AND AN AR-9545-T15-03 DRIVER SHAFT WAS TWISTED AND BENT OVER TIME AND UNABLE TO BE USED AS INTENDED. THE CASE WAS COMPLETED WITHOUT ADVERSE EFFECTS ON THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21632457 ↗
• MalfunctionMar 18, 2025Material Twisted/Bent; Material Twisted/Bent

  ON 03/03/2025, A SALES REPRESENTATIVE REPORTED VIA SEMS-(B)(4) THAT A (QTY. (B)(4)) OF AN AR-9545-T15-01 DRIVER SHAFT AND AN AR-9545-T15-03 DRIVER SHAFT WAS TWISTED AND BENT OVER TIME AND UNABLE TO BE USED AS INTENDED. THE CASE WAS COMPLETED WITHOUT ADVERSE EFFECTS ON THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21632448 ↗
• MalfunctionMar 14, 2025Material Twisted/Bent; Material Twisted/Bent

  ON 02/24/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9545-T15-01 DRIVER SHAFT TWISTED WHILE PUTTING THE STEM AND CUP TOGETHER. THE CASE CONTINUED AND WAS COMPLETED SUCCESSFULLY. THIS WAS DISCOVERED DURING A RTSA PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21606136 ↗
• MalfunctionMar 11, 2025Use of Device Problem; Use of Device Problem

  ON 02/21/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9545-T15-01 DRIVER SHAFT DID NOT FUNCTION. THIS OCCURRED IN A CASE, THEY HAD A SPARE DRIVER AND COMPLETED THE CASE WITHOUT INCIDENT OR DELAY.

  Patient problems: Insufficient Information

  MAUDE report 21571921 ↗
• MalfunctionFeb 26, 2025Material Twisted/Bent; Material Twisted/Bent

  ON 02/18/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9545-T15-01 DRIVER SHAFT TWISTED WHILE PUTTING THE STEM AND CUP TOGETHER. THE CASE CONTINUED AND WAS COMPLETED SUCCESSFULLY. THIS WAS DISCOVERED DURING A RTSA PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21471802 ↗
• MalfunctionFeb 26, 2025Material Twisted/Bent; Material Twisted/Bent

  ON 02/18/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9545-T15-01 DRIVER SHAFT TWISTED. THIS OCCURRED DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2025 WHILE PUTTING THE STEM & CUP TOGETHER THE DRIVER TWISTED. THE CASE CARRIED ON AND WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21471420 ↗
• MalfunctionFeb 24, 2025Material Deformation; Material Deformation

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT TWO AR-9545-T15-01 HEX DRIVERS WERE OVERTORQUED AND THE BIT HAS SPUN AND NO LONGER MAKES CONTACT WITH THE SCREW ON THE SUTURE CUP ENOUGH TO TIGHTEN IT TO THE STEM. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21445053 ↗
• MalfunctionFeb 24, 2025Material Deformation; Material Deformation

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT TWO AR-9545-T15-01 HEX DRIVERS WERE OVERTORQUED AND THE BIT HAS SPUN AND NO LONGER MAKES CONTACT WITH THE SCREW ON THE SUTURE CUP ENOUGH TO TIGHTEN IT TO THE STEM. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21444885 ↗
• MalfunctionDec 6, 2024Break; Break

  ON 11/13/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06710526 THAT AN AR-9545-T15-01 DRIVER SHAFT TINE BROKE OFF WHILE INSERTING THE SCREW. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20869025 ↗
• MalfunctionSep 10, 2024Break; Break

  ON 08/16/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 2) OF AN AR-9545-T15-01 DRIVER SHAFT AND AN AR-601-TBC8 IBALANCE UKA, TIBIAL BEARING TRIAL WAS BROKEN (PURCHASED AS PART OF SET AR-9501HS UNIVERS REVERS HUMERAL INSTRUMENT SET). THERE WAS NO CASE INVOLVEMENT.

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

  MAUDE report 20180011 ↗
• MalfunctionSep 6, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ECLIPSE WITH UNIVERSAL GLENOID SURGERY THE SCREWDRIVER BROKE OFF WHEN TIGHTENING THE SCREW. A PART OF THE DEVICE WAS STILL IN THE SCREW HEAD. THE INLAY RECESS WAS RAISED, AS THE SCREW HEAD WAS MINIMALLY PROTRUDING. THE SURGERY WAS FINISHED SUCCESSFULLY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 20159133 ↗
• MalfunctionSep 4, 2024Break; Break

  ON 08/09/2024 ADDITIONAL INFORMATION WAS PROVIDED BY A SALES REPRESENTATIVE VIA EMAIL WHO STATED THAT THE EVENT DATE WAS (B)(6) 2024. THE TYPE OF PROCEDURE PERFORMED WAS AN RTSA. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. A BACKUP TRAY WITH THE SAME INSTRUMENTS WERE USED TO COMPLETE THE PROCEDURE. 14892.

  Patient problems: Insufficient Information

  MAUDE report 20138339 ↗
• MalfunctionJul 25, 2024Break; Break

  ON 07/08/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS- (B)(4). THAT (QTY. 2) OF AN AR-9545-T15-03 DRIVER SHAFT, (QTY. 1) OF AN AR-9545-T15-02 DRIVER SHAFT, AND (QTY. 1) OF AN AR-9545-T15-01 DRIVER SHAFT WERE ALL STRIPPED WHEN TRYING TO REMOVE A SCREW. THE HEAD OF THE AR-9545-T15-01 DRIVER SHAFT STRIPPED OFF THE INSIDE OF THE SCREW INSIDE THE PATIENT, AND ALL PIECES WERE RETRIEVED FROM THE PATIENT. THE CASE WAS COMPLETED WITH THE GLENOID COMPONENT REMOVED WITH A DIAMOND BURR, AND THEN A CA HEAD WAS PUT ON THE HUMERAL SIDE. THERE WAS A SLIGHT DELAY DUE TO THE SCREW HEAD BREAKING OFF ON THE AR-9545-T15-01 DRIVER SHAFT. NO ADVERSE EFFECTS ON THE PATIENT. THIS WAS DISCOVERED DURING A REVISION REVERSE ARTHROPLASTY PROCEDURE ON (B)(4) 2024, WITH NO REPORTED PATIENT HARM.ADDITIONAL INFORMATION WAS RECEIVED ON 7/10/2024:THIS WAS A REVISION SURGERY FOR AN ARTHREX REVERSE SHOULDER WITH A CONVERTIBLE BASEPLATE BECAUSE THE BASEPLATE WAS ANGLED TOO SUPERIORLY, CAUSING EXTREME GLENOID NOTCHING OVER TIME AND ERODING THE INFERIOR GLENOID. THE TIP OF THE AR-9545-T15-01 DRIVER SHAFT BROKE DURING SCREW REMOVAL AND CAUSED THEM TO USE A DIAMOND BURR TO REMOVE THE BASEPLATE. THE ORIGINAL DATE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19829318 ↗
• MalfunctionJun 24, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 05/29/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9545-T15-01 DRIVER SHAFT WAS TWISTED. THIS WAS DISCOVERED POST CASE.

  Patient problems: Insufficient Information

  MAUDE report 19595647 ↗
• MalfunctionJun 19, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 05/23/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) 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 19570564 ↗
• MalfunctionJun 17, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED DURING A REVISION RSA, ALL FOUR T15 DRIVER BITS TWISTED AND WARPED WHILE TRYING TO REMOVE THE 6.5MM CENTRAL SCREW OF THE UNIVERSAL CONVERTIBLE BASEPLATE. PERIPHERAL SCREWS REMOVED FINE BUT THE CENTRAL SCREW WOULD NOT MOVE, AND THE BITS WOULD TWIST BEFORE THE SCREW WOULD MOVE. CENTRAL SCREW WAS REMOVED BY USING A DIFFERENT DRIVER BIT. SEE SOURCE DATA AND IMAGE ATTACHED. THE PART NUMBER(S) OF EXPLANTED PRODUCT IS CURRENTLY UNKNOWN. ADDITIONAL INFORMATION RECEIVED ON 3/8/21: THE REP REPORTED THE PRIMARY PROCEDURE TOOK PLACE APPROXIMATELY FOUR YEARS AGO AT THE SAME FACILITY WHERE THE REVISION WAS PERFORMED. THE REVISION SURGERY TOOK PLACE DUE TO PAIN AND POSSIBLE INFECTION. THE REP REPORTED THEY ARE UNABLE TO PROVIDE THE PART AND LOT NUMBERS OF EXPLANTED PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19547227 ↗
• MalfunctionJun 6, 2024Break; Break

  IT WAS REPORTED ON 11/18/2022 BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9545-T15-01 DRIVER SHAFT, AR-9545-T15-02 DRIVER SHAFT, AND AR-9545-T15-03 DRIVER SHAFT IS BROKEN. CASE INVOLVEMENT, NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19476256 ↗
• MalfunctionMay 16, 2024Defective Device; Defective Device

  ON 04/19/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9545-T15-01 DRIVER SHAFT IS DAMAGED NON-SPECIFICALLY. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19329749 ↗
• MalfunctionFeb 14, 2024Break; Break

  ON 01/26/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9545-T15-01 DRIVER SHAFT TIP BROKE. THIS OCCURRED DURING A CASE WITH NO NEGATIVE IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18704912 ↗
• MalfunctionJan 4, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 12/07/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06425314 THAT AN AR-9545-T15-01 DRIVER IS TWISTED. THIS WAS DISCOVERED DURING USE IN A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18446209 ↗
• MalfunctionDec 7, 2023Material Twisted/Bent; Material Twisted/Bent

  ON 11/10/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9545-T15-01 DRIVER SHAFT TIP IS BENT. THIS WAS DISCOVERED DURING USE IN A CASE WITH NO PATIENT HARM. "ITEMS DID NOT AFFECT THE OUTCOME TO THE CASE OR NEGATIVELY IMPACT THE PATIENT. ALL CASES PROCEEDED AS NORMAL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18287180 ↗
• MalfunctionMay 18, 2023Break; Break

  IT WAS REPORTED THAT DURING A PROSTHETICS SURGERY THE DRIVER BROKE OFF. ALL BROKEN PARTS WERE RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16952758 ↗