MAUDE Adverse Event Report: ARTHREX, INC. DRILL JACOBS CHUCK 0-7.4MM; POWERED SURG ORTHOPEDIC INSTR

Model Number	DRILL JACOBS CHUCK 0-7.4MM
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
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
It was reported that the customer sent a picture showing that the approach has fallen apart in practice.There was no harm for patient, operator or third party reported.There was no case involvement reported.No further information received.Update kpilz 20-oct-2025: further information was received that during a surgery the device got blocked and fell apart.The device has been reassembled and was used to fiinish the surgery successfully.It was not necessary to switch the surgical technique or do a second surgery.Per complaint reporter there was no harm for patient, operator or third party.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The manufacturer evaluation revealed the gear ring at the drill chuck and the bearing are worn out.

• Brand Name: DRILL JACOBS CHUCK 0-7.4MM
• 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: 23367088
• Report Number: 1220246-2025-04775
• Device Sequence Number: 21362788
• Product Code: HWE
• UDI-Device Identifier: 00888867223462
• UDI-Public: (01)00888867223462(10)10144785
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2025

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: DRILL JACOBS CHUCK 0-7.4MM
• Device Catalogue Number: AR-400DJ74
• Device Lot Number: 10144785
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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