Arthrex® AR-9510-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00888867290464), received between May 10, 2021 and Jun 3, 2026 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Break” (18 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING THE UNIVERS REVERS SHOULDER SURGERY, IT WAS FOUND THAT THE HUMERAL BROACH WAS VERY DIFFICULT TO ATTACH TO THE BROACH HANDLE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE WAS USED 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 25374130 ↗
• MalfunctionDec 2, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 11/10/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9510-2 REVERS LEVER-LOCKING BROACH HANDLE AND AN AR-9510-01 UNIVERS REVERS VERSION ROD EXPERIENCED AN ISSUE. WHEN USED TO BROACH, THE VERSION ROD AR-9510-01 SNAPPED OFF OF THE BROACH HANDLE AND WAS STUCK IN THE AR-9510-2. IT WOULD NOT THREAD BACK INTO THE SPOT IT NEEDS TO BE IN. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23691624 ↗
• MalfunctionFeb 19, 2025Device Damaged by Another Device; Device Damaged by Another Device

  ON 02/04/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9510-01 VERSION ROD HAD THE TIP BREAK OFF INSIDE THE AR-9510-2 UNIVERS REVERS LEVER-LOCKING BROACH HANDLE. A SECONDARY BROACH HANDLE AND VERSION ROD WAS PRESENT IN THE SET AND WAS USED TO COMPLETE THE CASE. NO 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 21411722 ↗
• MalfunctionDec 6, 2024Break; Break

  IT WAS REPORTED THAT DURING A SURGERY THE DEVICE BROKE. THE DEVICE IS STILL STUCK IN THE DEVICE AR-9510-2, BATCH: 052246-R. THE SURGERY WAS FINISHED SUCCESSFULLY. NO FURTHER INFORMATION RECEIVED. UPDATE KPILZ 03-DEZ-2024: FURTHER INFORMATION WERE RECEIVED THAT THE DEVICE BROKE DURING A SHOULDER PROTHESIS SURGERY. THE DEVICE BROKE OUTSIDE OF THE PATIENT. PER COMPLAINT REPORTER 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 20859788 ↗
• MalfunctionOct 10, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT THE DEVICE IS DEFECTIVE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION WAS RECEIVED WITH THIS DEVICE. IT WILL BE PROCESSED AS REPAIR, NOT AS COMPLAINT. UPDATE AVOE 01-OCT-2024: IT WAS FURTHER REPORTED THAT THE FAILURE OCCURRED DURING A SHOULDER PROSTHESIS SURGERY ON THE (B)(6) 2024. THE BOLT IN THE LOWER PART OF THE BRACKET IS MISSING AND THE RASP IS UNSTABLE IN THE HOLDER. ACCORDING TO THE SURGEON 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 20417740 ↗
• MalfunctionJun 7, 2024Break; Break

  ON 04/06/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9510-2 LEVER-LOCKING BROACH HANDLE BROKE. THIS OCCURRED DURING AN RTSA ON (B)(6) 2023, THE DEVICE DID NOT BREAK INSIDE THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 12/19/2023, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING INFORMATION VIA EMAIL: NO PIECE OF THE INSTRUMENT BROKE INSIDE THE PATIENT. A SECOND AR-9510-2 LEVER-LOCKING BROACH HANDLE IN THE SET WAS USED TO COMPLETE THE CASE SUCCESSFULLY. THERE WAS NO CASE DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19486365 ↗
• MalfunctionJun 7, 2024Break; Break

  ON 09/06/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-9510-2 LEVER-LOCKING BROACH HANDLES TRIGGER BROKE OFF. THIS OCCURRED ON (B)(6) 2022 DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY WHEN THE SURGEON WAS MALLETING OUT THE BROACH FROM THE HUMERUS. THERE WAS NO PATIENT EFFECT REPORTED, THE DEVICE DID NOT BREAK INSIDE THE PATIENT. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19484515 ↗
• MalfunctionJun 6, 2024Break; Break

  IT WAS REPORTED ON 11/30/2022 BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9510-2 BROACH HANDLE TIP BROKE AND IS STUCK IN THE HOUSING. CASE INVOLVEMENT, NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19476610 ↗
• MalfunctionApr 25, 2024Break; Connection Problem; Break; Connection Problem

  IT WAS REPORTED THAT DURING AN ARTHROPLASTY PROCEDURE, THE AR-9510-2 LOT: 031847, BROACH HANDLE BROKE. THE DEVICE WAS OUTSIDE OF THE BODY AND THE CASE WAS COMPLETED BY USING A NEW DEVICE. NO PATIENT HARM. IMAGES ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19182892 ↗
• MalfunctionMar 8, 2024Break; Break

  ON 02/23/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9510-2 UNIVERS REVERS LEVER-LOCKING BROACH HANDLE IS BROKEN. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18867639 ↗
• MalfunctionFeb 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 2/12/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT DURING A REVERS TOTAL SHOULDER PROCEDURE ON (B)(6) 2024, TWO BROACH HANDLES, AR-9510-2, WERE COMING OFF THE BROACH WHEN TRYING TO MALLET OUT OF THE HUMERAL CANAL. IN ADDITION, THE BASEPLATE INSERTER, AR-9623, WOULD NOT COME OFF THE BASEPLATE. THE BLUE WHEEL ON THE HANDLE WAS SPINNING BUT WOULD NOT BACK OFF THE BASEPLATE. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED 2/20/2024: THE CASE WAS COMPLETED WITH ONE OF THE BROACHES THAT WOULD HOLD ONTO THE BROACH BETTER THAN THE OTHER. THE BROACH HANDLES WILL BE RETURNED.

  Patient problems: Insufficient Information

  MAUDE report 18806732 ↗
• MalfunctionFeb 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 2/12/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(6) THAT DURING A REVERS TOTAL SHOULDER PROCEDURE ON (B)(6) 2024, TWO BROACH HANDLES, AR-9510-2, WERE COMING OFF THE BROACH WHEN TRYING TO MALLET OUT OF THE HUMERAL CANAL. IN ADDITION, THE BASEPLATE INSERTER, AR-9623, WOULD NOT COME OFF THE BASEPLATE. THE BLUE WHEEL ON THE HANDLE WAS SPINNING BUT WOULD NOT BACK OFF THE BASEPLATE. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18806705 ↗
• MalfunctionJan 10, 2024Use of Device Problem; Use of Device Problem

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9510-2 REVERS LEVER-LOCKING BROACH HANDLE IS NOT FUNCTIONING WELL. WHEN IT CLICKS IN THE BROACH, IT DOESN¿T ALWAYS HOLD THE BROACH IN PLACE. THIS WAS DISCOVERED DURING A PROCEDURE. THE CASE WAS COMPLETED WITH ANOTHER DEVICE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18483992 ↗
• MalfunctionDec 27, 2023Break; Break

  ON 11/30/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9510-2 REVERS LEVER-LOCKING BROACH HANDLE WAS BROKEN. THE CASE WAS COMPLETED USING A SECOND HANDLE THAT WAS BROUGHT AS A BACK UP. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18398563 ↗
• MalfunctionDec 15, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ON (B)(6) 2023, OUR NZ FIELD STAFF WERE ADVISED VIA EMAIL OF AN INCIDENT THAT OCCURRED IN CONJUNCTION WITH CASE(B)(4) WHERE AFTER DISCOVERING DEBRIS IN THE BROACH HANDLE FURTHER INSPECTIONS AND CLEANING WERE REQUESTED FROM THE CSSD DEPARTMENT WHERE ADDITIONAL DEBRIS WAS DISCOVERED. THIS DEBRIS WAS REMOVED AT THE CLEANING STAGES IN CSSD AND THE DEVICES WERE PROCESSED FOR USE IN THE FUTURE SURGERY. NO CASE OR PATIENT INVOLVEMENT WAS APPLICABLE.

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

  MAUDE report 18339470 ↗
• MalfunctionDec 15, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ON (B)(6) 2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-9510-2, REVERS LEVER-LOCKING BROACH HANDLE, HAD DEBRIS THAT CAME OUT OF IT ONTO THE STERILE SETUP. THE NURSE HANDED OUT THE BROACH HANDLE AND THE EQUIPMENT WAS THEN EXAMINED IN TSU WHEREIN MORE DEBRIS FELL OUT. IT WAS SENT TO LAB FOR CHECKING WHERE IT WAS CONFIRMED THAT THE DEBRIS WAS NOT PROTEIN. UPON CLEANING THE DEVICE AFTER THE INCIDENT, MORE DEBRIS WAS DISCOVERED IN THE HANDLE NEAR THE SPRING COMPONENT (REFER TO PICTURE A). IT WAS CLEANED THOROUGHLY UNTIL NO TRACE OF DEBRIS CAME OUT FROM THE HANDLE. THIS WAS DISCOVERED DURING THE SET UP FOR REVERSE TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2023. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A STERILE SET THAT CAME FROM TIMARU PUBLIC HOSPITAL AND WAS SENT FOR PROCESSING. THE PROCESS OF GOING THROUGH AUTOCLAVE STERILIZATION BREAKS CELLULAR BONDS AND DENATURE ANY PROTEIN. THE INDICATION WAS THAT THE DEBRIS WAS PRESENT FOR SOME TIME AND MAY HAVE BEEN THROUGH MULTIPLE STERILIZATION PROCESSES AND HAVE NO PROTEIN BONDS LEFT TO BREAK DOWN. THE HYPOTHESIS WAS THAT THE DEBRIS WAS OLD BIOLOGICAL MATTER BUILT UP FROM PREVIOUS USES INTRAOPERATIVELY. (B)(6) 2023 - INST

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

  MAUDE report 18337477 ↗
• MalfunctionNov 17, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9510-01 VERSION ROD AND AN AR-9510-2 LEVER-LOCKING BROACH HANDLE BROKE. THIS OCCURRED DURING A CASE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18164051 ↗
• MalfunctionJul 27, 2023Break; Break

  ON (B)(6)2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9510-2 BROACH HANDLE BROKE OFF THE THREADED PORTION OF THE VERSION ROD INTO THE 20° HOLE. THIS OCCURRED DURING A CASE, ANOTHER DEVICE WAS USED. THERE WAS NO EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17408405 ↗
• MalfunctionOct 4, 2022Break

  ON 7/21/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9510-2 UNIVERS REVERS LEVER-LOCKING BROACH HANDLE IS BROKEN. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME. ADDITIONAL INFORMATION RECEIVED ON 7/21/2022: THIS WAS DISCOVERED DURING A RTS PROCEDURE ON (B)(6) 2022. DURING INSERTION OF THE AR-9510-2 UNIVERS REVERS LEVER-LOCKING BROACH HANDLE, IT BROKE. SURGEON WAS ABLE TO REMOVE ALL BROKEN PIECES AND COMPLETE CASE WITHOUT FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15538166 ↗
• MalfunctionSep 6, 2022Break

  IT WAS REPORTED THAT DURING A UNIVERSE REVERSE SHOULDER SURGERY THE IMPACTOR OF THE DEVICE BROKE WHEN THE DEVICE WAS TAKEN OUT. THE SAMPLE RASP OF THE DEVICE WAS THEN REMOVED WITH THE THREADED ROD OF THE SIEVE. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15362248 ↗
• MalfunctionJul 11, 2022Break

  ON 6/24/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9510-2 REVERSE LEVER LOCKING BROACH HANDLE HAD AN ISSUE DURING A CASE. THE HANDLE BLEW OFF DURING THE CASE. ALL WAS RETRIEVED FROM THE PATIENT AND THERE WAS NO HARM. IT WAS REPLACED AND THERE WERE NO FURTHER COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14976762 ↗
• MalfunctionMay 16, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9510-2 BROACH HANDLE PEG THAT IS FIXED WITHIN THE SHAFT OF INSTRUMENT SLID OUT UPON FIRST RELEASE OF TRIGGER. THERE WAS NO PATIENT HARMED, THE BROKEN PEG WAS RETRIEVED AND THE CASE WAS COMPLETED WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14407097 ↗
• MalfunctionApr 18, 2022Break

  ON (B)(6) 2021, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-9510-2 BROACH HANDLES SPRING MECHANISM FELL APART. THIS OCCURRED DURING A CASE, WITH NO PATIENT EFFECT REPORTED. DURING RETURNED DEVICE EVALUATION, A REPORTABLE MALFUNCTION WAS DISCOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14136711 ↗
• MalfunctionApr 11, 2022Break

  ON 03/24/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9510-2 LEVER-LOCKING BROACH HANDLE FELL APART AS SURGEON WAS USING A MALLET TO INSERT IT IN THE HUMERUS. THIS WAS DISCOVERED DURING A RTSA PROCEDURE ON (B)(6) 2022 AND IT WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14075285 ↗
• MalfunctionMar 7, 2022Break

  ON (B)(6) 2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9510-2 REVERSE LOCKING BROACH HANDLE BROKE. THIS WAS DISCOVERED DURING USE IN A REVERSE TOTAL SHOULDER PROCEDURE ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 13684869 ↗