MAUDE Adverse Event Report: ARTHREX, INC. 2.8MM DRILL GUIDE; ORTHOPEDIC MANUAL SURG INSTR

Model Number	2.8MM DRILL GUIDE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2025
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 05/02/2025, it was reported by a sales representative via (b)(4) that an 0349-100 2.8mm drill guide and a 4040-000 calibrated drill were both damaged.No further information was provided.This was discovered during the case with no patient harm.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged 0349-100 2.8mm drill guide batch number: 230534 was received for investigation.Visual evaluation of the returned device noted significant damage to the device with superficial scratches and indentations observed.It was further noted that an 4040-000 calibrated drill was stuck with in it.The most likely cause for the observed damage can be attributed to misuse due to mishandling/use error.The most likely cause for the stuck 4040-000 calibrated drill can be attributed to user error due to prying/leveraging of the mating instrument within the cannulation of the 0349-100 2.8mm drill guide.Refer to investigation photos.

• Brand Name: 2.8MM DRILL GUIDE
• 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: 22097698
• Report Number: 1220246-2025-02260
• Device Sequence Number: 7424983
• Product Code: LXH
• UDI-Device Identifier: 00848665030082
• UDI-Public: (01)00848665030082(11)230721(10)230534
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/08/2025

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: 2.8MM DRILL GUIDE
• Device Catalogue Number: 0349-100
• Device Lot Number: 230534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Distributor Facility Aware Date: 05/02/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown