Arthrex® AR-9233Recalls & reported problems
Arthrex, Inc. · BROACH, PEGGED GLENOID · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Arthrex AR-9233 pegged glenoid broach is a hand surgical instrument used to prepare the shoulder socket during joint replacement surgery. The 47 reports mostly describe parts breaking off during surgery, such as the top hat, back plate, or impactor connection, sometimes with fragments left in the patient; a few mention the tool seizing up or becoming sticky and hard to clean. There are no deaths and no injuries. 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
- 47
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 00888867059443), received between Mar 8, 2021 and Mar 25, 2026 — classified as 47 malfunctions.
The most frequently reported specific device problem is “Break” (31 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.
Reports received per month
Most reported problems
Device problems
- Break31
- Device Difficult to Maintain5
- Physical Resistance/Sticking3
- Detachment of Device or Device Component2
- Failure to Advance2
- Defective Device1
- Difficult to Remove1
- Dull, Blunt1
Patient problems
- No Clinical Signs, Symptoms or Conditions35
- Insufficient Information12
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 25, 2026Detachment of Device or Device Component
ON 05-MAR-2026, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT THE TOP HAT OF THE AR-9233 PEGGED GLENOID BROACH POPPED OFF WHEN HIT WITH A MALLET DURING A CASE. NO PATIENT WAS AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24690074 ↗MalfunctionDec 23, 2025Use of Device Problem; Use of Device Problem
ON 12/02/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9233 BROACH DID NOT PULL IN OR OUT ANY LONGER AS DESIGNED. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23878328 ↗MalfunctionDec 22, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON 12/01/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9233 BROACH SEIZED UP INTERNALLY DURING USE. NO CASE INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP ON 12/8/25. THE DEVICE WAS "SLUDGY AND STICKY" WITH NO WAY TO CLEAN THE BIO BURDEN. THE ISSUE WAS DISCOVERED AFTER A TOTAL SHOULDER ARTHROPLASTY WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23863689 ↗MalfunctionNov 4, 2025Break; Break
ON 10/22/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9233 PEGGED GLENOID BROACH BACK PLATTER BROKE OFF WHEN THE SURGEON NAILED THE BACK OF IT DURING A PROCEDURE. NO PATIENT WAS AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23463127 ↗MalfunctionMay 29, 2025Break; Break
ON 05/12/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9233 BROACHS END BROKE OFF WHERE IT CONNECTS TO THE IMPACTOR PAD. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22110065 ↗MalfunctionMar 18, 2025Break; Break
IT WAS REPORTED THAT DURING A SHOULDER PROSTHESIS SURGERY THE IMPACT HEAD OF THE DEVICE BROKE OFF. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITHOUT CHANGING THE 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 21633146 ↗MalfunctionFeb 25, 2025Break; Break
ON 02/12/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9233 PEGGED GLENOID BROACH BROKE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. NO DELAY IN CASE. ALL FRAGMENTS WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21461577 ↗MalfunctionSep 19, 2024Naturally Worn; Naturally Worn
ON 09/11/2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA (B)(4) THAT AN AR-9233 GUIDE BROACH HAD BEEN DAMAGED FROM HEAVY USE. THIS WAS DISCOVERED DURING A CASE, AND AN ALTERNATE INSTRUMENTATION WAS USED TO PROCEED.
Patient problems: Insufficient Information
MAUDE report 20260651 ↗MalfunctionAug 5, 2024Break; Break
ON 07/15/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-(B)(4) THAT AN AR-9233 GUIDE BROACH BROKE. THIS OCCURRED DURING A CASE THEY WERE STILL ABLE TO COMPLETE THE CASE WITH NO ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.
Patient problems: Insufficient Information
MAUDE report 19905086 ↗MalfunctionJul 17, 2024Break; Break
ON 06/28/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS- (B)(4) THAT AN AR-9233 GUIDE BROACH BACK CAP SHEARED FROM INNER SLEEVE. THE PATIENT WAS NOT AFFECTED. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 7/2/2024: THIS EVENT OCCURRED WHILE INSIDE THE PATIENT, AND ALL FRAGMENTS WERE RETRIEVED. THE SURGEON HAD ALREADY BROACHED ENOUGH, AND THE INSTRUMENT WAS BROKEN UPON FINAL IMPACTION, SO IT BROKE RIGHT WHEN THEY FINISHED WITH THE AR-9233 GUIDE BROACH. THIS WAS DISCOVERED DURING A TOTAL SHOULDER ARTHROPLASTY (ECLIPSE/VAULTLOCK) PROCEDURE ON (B)(6)2024. THERE WAS NO DELAY IN THE CASE, AND IT WAS COMPLETED SUCCESSFULLY. PHOTOS ARE ATTACHED OF THE COMPLAINT DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19764007 ↗MalfunctionJul 3, 2024Break; Break
ON 6/6/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9233 GUIDE BROACH WAS BROKEN WITH NO FURTHER INFORMATION PROVIDED. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 6/12/2024: THE AR-9233 GUIDE BROACH BROKE WHILE BEING REMOVED FROM THE BONE WITH A MALLET. IT WAS REMOVED WHILE INSIDE THE PATIENT. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THERE WAS NO DELAY IN THE CASE. THIS WAS DISCOVERED DURING A TOTAL SHOULDER PROCEDURE ON (B)(6) 2024. THE CASE WAS COMPLETED WITH A SECONDARY BROACH. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT DUE TO THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19671205 ↗MalfunctionJun 19, 2024Break; Break
IT WAS REPORTED ON 11/30/2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9233 GLENOID BROACH MALLEATING PART FELL OFF DURING IMPLANT PREP . CASE INVOLVEMENT, NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19570591 ↗MalfunctionJun 18, 2024Break; Break
ON (B)(6) 2022, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS THAT A AR-9233 PEGGED GLENOIDS HANDLE IS BROKEN ON THE BOTTOM. THIS WAS DISCOVERED AT THE END OF AN UNKNOWN PROCEDURE, THERE WAS NO DELAY OR PATIENT EFFECT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19559174 ↗MalfunctionJun 14, 2024Break; Break
IT WAS REPORTED THAT THE AR-9233, BROACH, TSA GLENOID PEGGED/KEELED IS BROKEN. ADDITIONAL INFORMATION 3/25/2021 PLEASE NOTE THAT THE INSTRUMENT WAS BROKEN PRIOR TO THE CASE, BUT IT WASN¿T NOTICED UNTIL AFTER THE CASE START.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19537623 ↗MalfunctionJun 13, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT THE AR-9233, HAS A STICKY SLIDING MECHANISM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19528122 ↗MalfunctionJun 6, 2024Break; Break
IT WAS REPORTED ON 10/28/2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9233 GLENOID BROACH IMPACTOR PAD BROKE OFF WHILE INSERTING. CASE INVOLVEMENT, NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19478348 ↗MalfunctionJun 6, 2024Failure to Advance; Failure to Advance
ON 11/1/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN AR-9233 BROACH IS NOT SLIDING. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME WITH NOT PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19475222 ↗MalfunctionMay 25, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED ON 02/23/2022 BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-9233 GLENOID BROACH IS STUCK, PREVENTING THE DEVICE FROM WORKING PROPERLY. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19398264 ↗MalfunctionMay 22, 2024Break; Break
ON 09/20/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A AR-9233 GUIDE BROACH'S BACK PIECE IS SHEARED OFF, THERE IS NOTHING TO MOUNT IT ON OR OFF. THIS OCCURRED DURING AN UNKNOWN CASE WITH NO PATIENT EFFECT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19369677 ↗MalfunctionMay 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED DURING AN APEX TOTAL SHOULDER PROCEDURE THE END OF THE BROACH HANDLE FELL OFF WHEN IMPACTED WITH THE SLAP HANDLE. THE BROACHING PROCEDURE WAS COMPLETED WHEN THIS OCCURRED SO NO REPLACEMENT WAS NEEDED. THERE WERE NO FURTHER ISSUES AND THE CASE WAS COMPLETED. TO DATE, THE PATIENT IS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19357985 ↗MalfunctionMay 14, 2024Defective Device; Defective Device
IT WAS REPORTED ON 07/14/2022 BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-9233 PUNCH IS NOT SLIDING FREELY AND GETTING STUCK. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19311637 ↗MalfunctionMay 14, 2024Failure to Advance; Failure to Advance
ON 07/13/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A AR-9233 BROACH IS NOT SLIDING FREELY, AND IS UNABLE TO BE TAKEN APART. THIS OCCURRED DURING AN UNKNOWN CASE, WITH NO PATIENT EFFECT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19311198 ↗MalfunctionApr 10, 2024Device Difficult to Maintain; Device Difficult to Maintain
PER LOAN / CONSIGNMENT INSPECTIONS OPERATOR: THE INSTRUMENT CANNOT BE DISASSEMBLED AND IS DIFFICULT TO CLEAN, THEREFORE BIOLOGICAL RESIDUES SUCH AS BLOOD ACCUMULATE INSIDE THE INSTRUMENT AND BY MOVING THE "OUTER ROD", BLOOD RESIDUES CAN BE SEEN AT THE DISTAL END. THE PROBLEM WAS NOTICED AFTER THE SURGERY. THERE WAS NO HARM FOR THE PATIENT, OPERATOR OR THIRD PARTY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19078810 ↗MalfunctionApr 10, 2024Device Difficult to Maintain; Device Difficult to Maintain
PER LOAN / CONSIGNMENT INSPECTIONS OPERATOR: THE INSTRUMENT CANNOT BE DISASSEMBLED AND IS DIFFICULT TO CLEAN, THEREFORE BIOLOGICAL RESIDUES SUCH AS BLOOD ACCUMULATE INSIDE THE INSTRUMENT AND BY MOVING THE "OUTER ROD", BLOOD RESIDUES CAN BE SEEN AT THE DISTAL END. THE PROBLEM WAS NOTICED AFTER THE SURGERY. THERE WAS NO HARM FOR THE PATIENT, OPERATOR OR THIRD PARTY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19078551 ↗MalfunctionApr 10, 2024Device Difficult to Maintain; Device Difficult to Maintain
PER LOAN / CONSIGNMENT INSPECTIONS OPERATOR: THE INSTRUMENT CANNOT BE DISASSEMBLED AND IS DIFFICULT TO CLEAN, THEREFORE BIOLOGICAL RESIDUES SUCH AS BLOOD ACCUMULATE INSIDE THE INSTRUMENT AND BY MOVING THE "OUTER ROD", BLOOD RESIDUES CAN BE SEEN AT THE DISTAL END. THE PROBLEM WAS NOTICED AFTER THE SURGERY. THERE WAS NO HARM FOR THE PATIENT, OPERATOR OR THIRD PARTY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19078511 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page