MAUDE Adverse Event Report: ARTHREX, INC. REVERS BROACH/TRIAL, SIZE 5 MODULAR; ORTHOPEDIC MANUAL SURG INSTR

Model Number	REVERS BROACH/TRIAL, SIZE 5 MODULAR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a revers total shoulder arthroplasty the size 5 broach chipped off.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device (size 5 broach).It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The reported event is confirmed.The visual evaluation of the ar-9510-05mdm, batch 111970 revealed that the half of the snap-in edge is worn (see evaluation pictures 2 - 4).The most likely cause for the reported failure is the wear and tear damage incurred over repeated usage.

• Brand Name: REVERS BROACH/TRIAL, SIZE 5 MODULAR
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 21755166
• Report Number: 1220246-2025-01189
• Device Sequence Number: 15907995
• Product Code: LXH
• UDI-Device Identifier: 00888867354319
• UDI-Public: (01)00888867354319(11)221018(10)111970
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: REVERS BROACH/TRIAL, SIZE 5 MODULAR
• Device Catalogue Number: AR-9510-05MDM
• Device Lot Number: 111970
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2025
• Supplement Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown