Arthrex® AR-9545-T15-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00888867225176), received between Sep 21, 2016 and Nov 17, 2025 — classified as 13 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Break” (22 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2025Material Twisted/Bent; Material Twisted/Bent

  ON 10/31/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9545-T15-03 T-15 LONG-DRIVER SHAFT WAS TWISTED. THIS WAS NOTICED AFTER THE CASE, AND NO PATIENT WAS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23567772 ↗
• MalfunctionApr 23, 2025Material Twisted/Bent; Material Twisted/Bent

  ON 04/08/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(6), AN AR-9545-T15-03 DRIVER SHAFT TIP, WAS TWISTED DURING THE CASE. ANOTHER DEVICE WAS SWAPPED, AND 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 21893899 ↗
• 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 21632502 ↗
• MalfunctionFeb 7, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER PROSTHESIS SURGERY THE TIP OF THE SCREWDRIVER BROKE WHILE SCREWING THE CENTRAL SCREW INTO THE GLENOID. THE BROKEN TIP DID NOT REMAIN IN THE WOUND, IT WAS REMOVED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21333679 ↗
• MalfunctionOct 15, 2024Material Twisted/Bent; Material Twisted/Bent

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06671849 THAT AN AR-9545-T15-03 DRIVER SHAFT TIP WAS TWISTED AND WOULD NOT HOLD OR ENGAGE THE SCREW AND (QTY. 2) OF AN AR-9510-2 UNIVERS REVERS LEVER-LOCKING BROACH HANDLE SIDE LOCKING ARM MECHANISM WOULD NOT STAY LOCKED. THEY HAD A BACKUP SET AVAILABLE AND COULD PROCEED WITH THE CASE WITHOUT INCIDENT. THIS WAS DISCOVERED DURING A REVERSE TOTAL SHOULDER PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20453282 ↗
• MalfunctionOct 9, 2024Break; Break

  ON 09/19/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(6) 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 20411043 ↗
• MalfunctionJun 14, 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. 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: Insufficient Information

  MAUDE report 19539309 ↗
• MalfunctionMay 23, 2024Break; Break

  IT WAS REPORTED ON 11/18/2022 BY A SALES REPRESENTATIVE VIA SEMS 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 19380916 ↗
• 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-T15-03 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 18444158 ↗
• MalfunctionJan 3, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 11/10/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06398499 THAT AN AR-9545-T15-03 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 18440269 ↗
• MalfunctionDec 7, 2023Break; Material Twisted/Bent; Break; Material Twisted/Bent

  ON 11/10/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9165CDG BASEPLATE IMPACTOR PLASTIC TIP IS BROKEN. THIS WAS DISCOVERED AFTER USE IN A CASE WITH NO PATIENT HARM. "BROKEN ITEMS WERE DISCOVERED IN CLEANUP, DID NOT AFFECT THE OUTCOME OF THE CASE, AND DID NOT NEGATIVELY IMPACT THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18287198 ↗
• 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-T15-03 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 18287119 ↗
• MalfunctionNov 28, 2023Defective Device; Defective Device

  ON 10/30/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06070503 THAT AN AR-9545-T15-03 DRIVER SHAFT WAS DAMAGED. THIS OCCURRED DURING A CASE, WITH NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18220533 ↗
• MalfunctionOct 24, 2022Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY THE SCREW ATTACHMENTS GOT TWISTED. 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. DURING RETURNED DEVICE EVALUATION, A REPORTABLE MALFUNCTION WAS DISCOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15657366 ↗
• MalfunctionAug 1, 2022Break

  IT WAS REPORTED THAT THE DEVICE BROKE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15137913 ↗
• MalfunctionFeb 21, 2022Break; Material Twisted/Bent

  ON (B)(6)2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT TWO AR-9545-T15-03 DRIVER SHAFTS AND ONE AR-9545-T15-02 HAVE TIPS THAT ARE TWISTED AND BENT. IN ADDITION, THE PLASTIC TIPS OF THE AR-9165-CDG ARE BROKEN. THERE WERE NO FRAGMENTS BROKEN OFF OR ANY PATIENT AFFECT. ALL ITEMS WERE REPLACED AND THE CASE WAS COMPLETED SUCCESSFULLY. DURING RETURNED DEVICE EVALUATION, A REPORTABLE MALFUNCTION WAS DISCOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13569415 ↗
• MalfunctionJun 14, 2021Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING UNIVERSE REVERS AND MGS REVERS SHOULDER REPLACEMENT SURGERIES THE DEVICES AR-9545-T15-02 (LOT 8001928, 8001545, 8001643, 8002005), AR-9545-T15-03 (LOT 00888867225190, 00888607225190) AND AR-9625 (LOT 021924) BENT/TWIST AND BROKE WHEN INSERTING THE CENTRAL AND PERIPHERAL SCREWS INTO THE BASEPLATES. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENTS. ACCORDING TO THE SURGEONS NO HARM FOR PATIENTS, OPERATORS OR THIRD PARTY OCCURRED. THE SURGERIES WERE FINISHED SUCCESSFULLY WITH NEW DEVICES 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 11990578 ↗
• MalfunctionJun 14, 2021Break

  IT WAS REPORTED THAT DURING UNIVERSE REVERS AND MGS REVERS SHOULDER REPLACEMENT SURGERIES THE DEVICES AR-9545-T15-02 (LOT 8001928, 8001545, 8001643, 8002005), AR-9545-T15-03 (LOT 00888867225190, 00888607225190) AND AR-9625 (LOT 021924) BENT/TWIST AND BROKE WHEN INSERTING THE CENTRAL AND PERIPHERAL SCREWS INTO THE BASEPLATES. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENTS. ACCORDING TO THE SURGEONS NO HARM FOR PATIENTS, OPERATORS OR THIRD PARTY OCCURRED. THE SURGERIES WERE FINISHED SUCCESSFULLY WITH NEW DEVICES WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 11990566 ↗
• MalfunctionJun 7, 2021Material Twisted/Bent

  IT WAS REPORTED THAT DURING A UNIVERSE REVERSE PROSTHESIS SURGERY THE TIP OF THE SCREW DRIVER WAS BENT AND COULD NOT BE USED PROPERLY ANYMORE AS IT DID NOT FIT INTO THE SCREW HEAD PROPERLY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11947667 ↗
• MalfunctionMay 3, 2021Break

  THIS IS NOW REPORTABLE. DURING RETURNED DEVICE EVALUATION, A REPORTABLE MALFUNCTION WAS DISCOVERED. COMPLAINT CONFIRMED, ALL THREE DRIVE FEATURES WERE TWISTED. ONE OF THE THREE WAS ALSO BROKEN AND MISSING ABOUT 1/8 IN. IT IS STATED NO TORQUE INDICATING DEVICE WAS USED, WHICH IS RECOMMENDED TO PREVENT DAMAGING THE DEVICE. A LIKELY CAUSE OF THE EVENT IS CONTINUALLY APPLYING TORQUE.

  Patient problems: Insufficient Information

  MAUDE report 11761563 ↗
• MalfunctionMay 3, 2021Break

  IT WAS REPORTED THAT THE SCREW (AR-9145-30, LOT 19.02683) COULD BE INSERTED COMPLETELY, BUT THE TIP OF THE DEVICE (AR-9545-115-03) BROKE DURING THE FINAL TIGHTENING AND THE TIP REMAINED INSIDE THE PATIENT WITHIN THE HEAD OF THE SCREW. THE DEVICE WAS ALREADY BENT DURING THE INSERTION OF THE PREVIOUS SCREW. ACCORDING TO THE SURGEON THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE IMPLANTATION OF A UNIVERSAL GLENOID SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE 19-APR-2021: IT WAS CONFIRMED THAT BROKEN DEVICE REMAINING INSIDE THE PATIENT WAS USED TO FINISH THE PROCEDURE AND NO ADDITIONAL INCISIONS WERE NECESSARY.

  Patient problems: Foreign Body In Patient

  MAUDE report 11761335 ↗
• InjuryJun 5, 2019Break; Difficult to Remove; Material Twisted/Bent

  IT WAS REPORTED THAT THE FOLLOWING OCCURRED DURING A REVISION PROCEDURE TO REMOVE A COMPETITOR¿S DEVICE (ARTHROSURFACE HEMI CAP). AFTER REMOVAL OF THE COMPETITOR¿S DEVICE A REVERSE TOTAL SHOULDER PROCEDURE WAS THEN PERFORMED. DURING THE PROCEDURE AN ARTHREX AR-1999HH (RATCHETING HANDLE), LOT 8001640 WAS NOT RATCHETING CORRECTLY AND COULD NOT BE USED. WHILE BEING USED TO INSERT A CENTRAL SCREW, AN AR-9545-T15-03 (DRIVER SHAFT), LOT 8001643, TIP BROKE OFF IN THE HEAD OF THE SCREW. THE TIP WAS NOT RETRIEVED AND IT REMAINS IN THE SCREW IN THE PATIENT. AN AR-9545-T15-02, (DRIVER SHAFT), LOT 8001819, WAS ALSO USED AND IT WAS REPORTED THAT THE THREADS OF THE DRIVER WERE TWISTED WHEN TIGHTENING THE SUPERIOR SCREW. THE SUPERIOR PERIPHERAL SCREW AR-9145-42NL, LOT UNKNOWN, SNAPPED OFF AT THE SHAFT AND HALF OF THE SCREW WAS LEFT IN THE PATIENT UNRETRIEVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8670896 ↗
• InjuryMay 23, 2019Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A UNIVERSE REVERSE PROCEDURE THE TIP OF THE SCREWDRIVER BROKE OFF. THE SCREW WAS ALREADY FIXED TIGHTLY. THE TIP STILL REMAINS IN THE SCREW IN PATIENT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE WHICH WAS USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE 02-MAY-2019: THE REMAINING FRAGMENT IS FIXED AND CANNOT MOVE INSIDE PATIENT. THERE ARE NO CONSEQUENCES FOR PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8636819 ↗
• InjuryJan 16, 2019Break; Failure to Advance; Detachment of Device or Device Component; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A RT. TOTAL SHOULDER ARTHROPLASTY PROCEDURE A TOTAL OF FOUR DRIVERS STRIPPED. THE FIRST AR-9545-T15-03, DRIVER STRIPPED WHILE TIGHTENING THE 6.5 CENTRAL NON-LOCKING SCREW. AFTER THE FIRST DRIVER STRIPPED, AN AR-9545-T15-02 (LOT: 8001545) WAS USED TO FINISH IMPLANTING THE 6.5 CENTRAL NON LOCKING SCREW. IT WAS USED AGAIN FOR THE SUPERIOR PERIPHERAL 4.5 LOCKING SCREW AND SCREW STOPPED ADVANCING AND WAS STUCK PROUD. THE SURGEON COULD NOT ADVANCE (SEVERAL ATTEMPTS) OR EXTRACT IT. TIP OF THE DRIVER BROKE OFF IN THE SCREW WHEN APPROX. 1.5 MM PROUD. THE HEAD OF THE SCREW WAS BURRED DOWN. CORING REAMER COULD NOT SEAT, AND THE SCREW HEAD WAS CATCHING ON IT. SURGEON TOOK THE PROVISIONAL GLENOSPHERE HEAD AND TRIED TO MATE IT TO THE BASEPLATE BUT CONCLUDED THE GLENOSPHERE WOULD BE COMPROMISED IF UNABLE TO ACHIEVE PROPER CLEARANCE. SURGEON WAS ABLE TO BURR THE HEAD OF THE SCREW OFF FOR PROPER CLEARANCE. AFTER TIP OF THE SECOND DRIVER BROKE, AN AR-9202-T15H WAS BROUGHT IN. WHILE USING IT TO TIGHTEN THE INFERIOR PERIPHERAL 4.5 LOCKING SCREW, THE SCREW WOULD NOT ADVANCE AS IT NEARED THE BASEPLATE. SURGEON EXTRACTED SCREW BEFORE IT GOT STUCK AND WENT FROM A 36 LENGTH TO A

  Patient problems: No Code Available

  MAUDE report 8252205 ↗
• InjuryNov 13, 2018Break; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE TIP OF THE AR-9545-T15-03, DRIVER SHAFT, T-15 LONG BROKE IN CENTRAL SCREW HEAD DURING AN RTSA PROCEDURE. DURING THE SAME PROCEDURE, THE REP OPENED A PACKAGE THAT WAS SUPPOSED TO CONTAIN AR-9502F-39RCPC (LOT: 1800369), BUT THERE WAS A 42+6 SPACER INSIDE THE BOX INSTEAD. THE REP CONFIRMED THAT THE 42+6 SPACER WAS NOT USED DURING THE PROCEDURE. THE REP HAD A BACK UP AR-9502F-39RCPC THAT WAS AVAILABLE AND USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED ON 10/26/2018: THE REP STATED THAT THE TRINITY GUIDE WAS USED FOR THE CENTRAL SCREW. THE SCREW WAS INSERTED INTO THE CENTRAL HOLE CORRECTLY. THE DRIVER WAS USED WITH THE AR-9545-T15H, TORQUE INDICATING ADAPTER. THE REP CONFIRMED THAT THE SURGEON DID NOT EXCEED THE 5MM MARK ON THE TORQUE INDICATING ADAPTER. THE REP CONFIRMED THAT THE TIP OF THE DRIVER REMAINS IN THE HEAD OF THE CENTRAL SCREW. THE REP CONFIRMED THAT THERE NO ATTEMPTS WERE MADE TO REMOVE THE BROKEN TIP FROM THE SCREW HEAD. THE CASE WAS COMPLETED BY IMPACTING ENOUGH OF THE SCREW TO MAKE TO CENTRAL CHECKER SHOW GREEN. THE REP CONFIRMED THAT THIS WAS AN INITIAL SURGERY. THE REP CONFIRMED THAT T

  Patient problems: Foreign Body In Patient

  MAUDE report 8065577 ↗