MAUDE Adverse Event Report: ARTHREX, INC. REAMER GUIDE PIN, SZ 5 MOD (NEUTRAL); MANUAL INSTR, GENERAL SURGICAL

Model Number	REAMER GUIDE PIN, SZ 5 MOD (NEUTRAL)
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 10-feb-2026, it was reported by a sales representative via (b)(4) that an ar-9510rg-5c size 5 reamer guide pin was broken.This was discovered during a procedure with no patient harm.The case was completed with another device.Additional information provided 16-feb-2026: it was further reported this was discovered during a reverse total shoulder arthroplasty procedure with a 10-minute delay experienced and no additional anesthesia administered.Per the rep, the damage is at the base of the post, the post will not engage with the broach correctly.No pieces broke off and it was stated no obvious incident caused this problem, just something that was noticed during the case.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: REAMER GUIDE PIN, SZ 5 MOD (NEUTRAL)
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 24482314
• Report Number: 1220246-2026-01090
• Device Sequence Number: 10308756
• Product Code: MDM
• UDI-Device Identifier: 00888867280700
• UDI-Public: (01)00888867280700(11)230607(10)052246
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2026

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: REAMER GUIDE PIN, SZ 5 MOD (NEUTRAL)
• Device Catalogue Number: AR-9510RG-5C
• Device Lot Number: 052246
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown