MAUDE Adverse Event Report: ARTHREX, INC. MODULAR FLEXIBLE REAMER HEAD, Ø15.5MM

Model Number	MODULAR FLEXIBLE REAMER HEAD, Ø15.5MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 17-jan-2026, a facility representative reported via (b)(4) that a 0234-155 15.5 mm modular flexible reamer head broke during the intramedullary reaming of a femoral shaft.The hip nail procedure was completed successfully; however, the broken piece was not retrieved from the patient.It was reported that there was no other patient harm.Additional information was received on 04-feb-2026.The rep advised that there were two small fragments created in addition to the larger remaining portion of the reamer that was retrieved, and those two fragments remained in the patient.The rep stated that no attempt was made to retrieve the fragments, as they were midshaft and deemed impossible to retrieve.There was no delay encountered.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation is confirmed.- one unpackaged 0234-155 serial/batch number 211146 was received for investigation.- functional testing was not performed due to the damage to the device.- visual inspection noted that the device is significantly damaged where the femoral shaft attaches.- the most likely cause is attributed to misuse/use error due to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: MODULAR FLEXIBLE REAMER HEAD, Ø15.5MM
• Common Device Name: REAMER
• 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: 24308866
• Report Number: 1220246-2026-00512
• Device Sequence Number: 13176790
• Product Code: HSB
• UDI-Device Identifier: 00848665000986
• UDI-Public: (01)00848665000986(11)210810(10)211146
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K191598
• 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): 03/13/2026

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: MODULAR FLEXIBLE REAMER HEAD, Ø15.5MM
• Device Catalogue Number: 0234-155
• Device Lot Number: 211146
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 01/19/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2026
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown