MAUDE Adverse Event Report: ARTHREX, INC. MODULAR DRILL, 10­° FULL, 30 MM; POWERED SURG ORTHOPEDIC INSTR

Model Number	MODULAR DRILL, 10­° FULL, 30 MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2025
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 10/7/2025, it was reported by a sales representative via (b)(4) that an ar-9596-1030f modular drill's internal attachment retention spring is broken, and was stuck to the handle.Noticed during a case during attachment, with no patient effect.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged modular drill, 10° full, 30 mm (ar-9596-1030f), batch 021951, was received for investigation.Visual inspection noted: grind marks on the body.Surface damage on both the distal and proximal ends.The retention spring inside the device was damaged.Functional testing: not performed due to the extent of damage.Most likely cause: wear and tear damage incurred over time.Note: the manufacturing date is 2020.Complaint allegation: confirmed.Refer to the attached investigation photos.

• Brand Name: MODULAR DRILL, 10­° FULL, 30 MM
• Common Device Name: POWERED SURG ORTHOPEDIC 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: 23302687
• Report Number: 1220246-2025-04616
• Device Sequence Number: 9926404
• Product Code: HWE
• UDI-Device Identifier: 00888867346116
• UDI-Public: (01)00888867346116(11)200121(10)021951
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 01/02/2026

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 DRILL, 10­° FULL, 30 MM
• Device Catalogue Number: AR-9596-1030F
• Device Lot Number: 021951
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2020
• 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