Arthrex® AR-9545-T15-02Recalls & reported problems
Arthrex, Inc. · Driver Shaft, T-15, Medium · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is an Arthrex T-15 medium driver shaft, a hand tool used to place and remove screws during shoulder surgery. The reports mostly describe the shaft breaking or twisting mid-procedure, sometimes with the tip snapping off inside a screw or baseplate and needing to be retrieved. There are 59 reports, 17 injuries and no deaths; in most cases the surgery was completed without harm. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 59
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 00888867225190), received between Feb 22, 2017 and Mar 17, 2026 — classified as 17 injuries, 42 malfunctions.
The most frequently reported specific device problem is “Break” (41 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.
Reports received per month
Most reported problems
Device problems
- Break41
- Material Twisted/Bent20
- Entrapment of Device3
- Physical Resistance/Sticking3
- Difficult to Remove2
- Dull, Blunt2
- Appropriate Device Problem Term/Code Not Available1
- Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions30
- Insufficient Information11
- Device Embedded In Tissue or Plaque5
- Foreign Body In Patient4
- No Known Impact Or Consequence To Patient4
- No Information3
- No Code Available2
- Bone Fracture(s)1
Recent adverse event reports
The 25 most recent of 59 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 17, 2026Material Twisted/Bent
ON (B)(6), A SALES REPRESENTATIVE REPORTED VIA SEMS-(B)(4) THAT THE AR-9545-T15-02 T-15 DRIVER SHAFT IS TWISTED. THIS ISSUE WAS DISCOVERED AFTER A CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24621804 ↗MalfunctionMar 11, 2026Break
ON 18-FEB-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9545-T15-02 T-15, MEDIUM DRIVER SHAFT BROKE. THIS WAS DISCOVERED DURING A REVERSE TOTAL SHOULDER PROCEDURE WITH NO PATIENT HARM. NO PIECES BROKE OFF INSIDE THE PATIENT, AND THE CASE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24567232 ↗MalfunctionDec 1, 2025Break; Break
ON 11/10/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9545-T15-02 DRIVER SHAFT WAS BROKEN. NO FURTHER INFORMATION WAS PROVIDED. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23680302 ↗MalfunctionAug 7, 2025Break; Break
ON 07/18/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9545-T15-02 T-15 MEDIUM DRIVER SHAFT TIP BROKE OFF IN THE SCREW HEAD OF A SUTURE CUP WHILE ATTEMPTING TO REMOVE IT IN A REVISION SCENARIO. THE BROKEN PIECE WAS RETRIEVED. THE REVERSE TOTAL SHOULDER PROCEDURE WAS SUCCESSFULLY COMPLETED, AND NO PATIENT WAS HARMED. ADDITIONAL INFORMATION WAS RECEIVED ON 28-JUL-2025: THE ORIGINAL REVISION PURPOSE WAS DUE TO THE PATIENT DISLOCATING THEIR PROSTHESIS. THERE WAS NO ALLEGATION THAT THE REVISION WAS DUE TO A MALFUNCTION OF AN ARTHREX PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22738126 ↗MalfunctionAug 7, 2025Break; Break
ON 07/18/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9545-T15-02 DRIVER SHAFT TIP OF SCREWDRIVER WAS TORQUED AND BROKE AT THE HEAD OF THE SCREW WHILE TRYING TO REMOVE THE CENTRAL SCREW FROM THE CUG BASEPLATE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22737867 ↗MalfunctionOct 16, 2024Break; Break
ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT TWO (QTY.2) AR-9545-T15-02 AND AN AR-9545-T15-03 DRIVER SHAFTS ARE BROKEN. NO HARM WAS DONE TO THE PATIENT AND THE CASES FINISHED WITHOUT ANY NEGATIVE IMPACT. REPLACEMENTS WERE USED TO COMPLETE THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20460741 ↗MalfunctionOct 9, 2024Break; Break
ON 09/19/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT TWO (QTY.2) AR-9545-T15-02 AND AN AR-9545-T15-03 DRIVER SHAFTS ARE BROKEN. NO HARM WAS DONE TO THE PATIENT AND THE CASES FINISHED WITHOUT ANY NEGATIVE IMPACT. DR. ROMINE WAS THE SURGEON. REPLACEMENTS WERE USED TO COMPLETE THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20411054 ↗MalfunctionSep 4, 2024Break; Break
ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06467451 THAT AN AR-9545-T15-02 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 20134238 ↗MalfunctionJun 18, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE DRIVER WAS TORQUED DURING A REVERSE SHOULDER CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19563891 ↗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 19546803 ↗MalfunctionMay 23, 2024Break; Break
ON 10/14/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9545-T15-02 DRIVER SHAFTS END SHEARED OFF. THIS OCCURRED DURING AN UNSPECIFIED TIME, WITH NO PATIENT EFFECT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19380652 ↗MalfunctionMay 16, 2024Defective Device; Defective Device
ON 04/19/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9545-T15-02 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 19329966 ↗MalfunctionMar 19, 2024Break; Break
IT WAS REPORTED THAT DURING AN ECLIPSE WITH UNIVERSAL GLENOID SURGERY DURING IMPLANTATION OF THE UNIVERSAL GLENOID BASEPLATE THE INFERIOR PERIPHERAL SCREW GOT JAMMED. WHEN TRYING TO SCREW IT IN, THE HEAD OF THE SCREWDRIVER BROKE OFF AND GOT STUCK IN THE SCREW HEAD. THIS HAD TO BE REMOVED USING THE OPERACE SYSTEM. THE SCREW HEAD BROKE OFF IN THE PROCESS. THE REST OF THE SCREW REMAINED IN THE PATIENT AND THE BASEPLATE WAS LEFT AS IT WAS. THE INLAY WAS THEN PLACED ON TOP AND THE SURGERY WAS COMPLETED AS NORMAL. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18935440 ↗MalfunctionFeb 14, 2024Break; Break
ON 01/26/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9545-T15-02 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 18705059 ↗MalfunctionFeb 14, 2024Break; Break
ON 01/26/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9545-T15-02 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 18703945 ↗MalfunctionJan 4, 2024Material Twisted/Bent; Material Twisted/Bent
ON (B)(6) 2023 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06425314 THAT AN AR-9545-T15-02 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 18446091 ↗MalfunctionJan 4, 2024Material Twisted/Bent; Material Twisted/Bent
ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9545-T15-02 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 18444676 ↗MalfunctionDec 15, 2023Break; Positioning Failure; Break; Positioning Failure
ON 11/15/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06402230 THAT AN AR-9545-T15-02 DRIVER SHAFT HAD A DAMAGED TIP AND WILL NOT FIT IN THE SCREW. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18337900 ↗MalfunctionDec 7, 2023Material Twisted/Bent; Material Twisted/Bent
ON 11/10/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06398499 THAT AN AR-9545-T15-02 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 18287201 ↗MalfunctionNov 29, 2023Dull, Blunt; Dull, Blunt
IT WAS REPORTED THAT DURING A SHOULDER PROSTHESIS SURGERY IT WAS NOTICED THAT THE DRIVER IS DULL AND THE SCREWDRIVER FELL APART OUTSIDE OF THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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 18226580 ↗MalfunctionNov 17, 2023Break; Break
ON (B)(6)2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9545-T15-02 DRIVER SHAFT HEAD BECAME TWISTED AND BROKE OFF. THIS OCCURRED DURING A CASE, THE FRAGMENT WAS RETRIEVED AND THE CASE WAS COMPLETED.
Patient problems: Insufficient Information
MAUDE report 18163932 ↗MalfunctionJan 9, 2023Break
ADDITIONAL INFORMATION RECEIVED ON 12/20/2022: THE SHAFT BROKE INSIDE THE PATIENT AND SURGEON WAS ABLE TO REMOVE ALL BROKEN FRAGMENTS. CASE WAS COMPLETE WITH ANOTHER AR-9545-T15-02 DRIVER SHAFT. PROCEDURE TOOK PLACE ON (B)(6) 2022.
Patient problems: Insufficient Information
MAUDE report 16120331 ↗MalfunctionNov 11, 2022Break
IT WAS REPORTED ON 10/18/2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9545-T15-02 DRIVER TIP IS BROKEN OFF. THIS WAS DISCOVERED DURING A CASE AND BROKE INSIDE THE JOINT SPACE.
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 15781538 ↗MalfunctionOct 24, 2022Break
IT WAS REPORTED ON (B)(6) 2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9545-T15-02 DRIVER SHAFT AND AR-9545-T15-03 DRIVER SHAFT IS STRIPPED. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM. DURING RETURNED DEVICE EVALUATION, A REPORTABLE MALFUNCTION WAS DISCOVERED.
Patient problems: Insufficient Information
MAUDE report 15657398 ↗MalfunctionOct 24, 2022Material Twisted/Bent
IT WAS REPORTED ON (B)(6) 2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9545-T15-02 AND AR-9545-T15-03 DRIVER SHAFT ARE TWISTED. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME WITH NO PATIENT HARM. DURING RETURNED DEVICE EVALUATION, A REPORTABLE MALFUNCTION WAS DISCOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15657386 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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