MAUDE Adverse Event Report: ARTHREX, INC. 3.0MM MGS DRILL BIT, STERILE; POWERED SURG ORTHOPEDIC INSTR

Model Number	3.0MM MGS DRILL BIT, STERILE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2025
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 during an invers shoulder prothesis surgery the drill broke at the welding point.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The reported event was confirmed as one unpackaged, ar-9628s, 3.0 mm mgs drill bit was received for investigation and the evaluation revealed that the weld seam on the shaft is broken (see evaluation pictures 1 + 2) and therefore the connecting head is missing.Further, the cutting edges are worn (see evaluation picture 3) and the paint groove chips partly (see evaluation picture 4).Functional testing was not performed due to the damage of the device.The most likely cause for the reported failure can be attributed to misuse due to excessive user-applied mechanical forces.

• Brand Name: 3.0MM MGS DRILL BIT, STERILE
• 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: 23061592
• Report Number: 1220246-2025-03868
• Device Sequence Number: 15919258
• Product Code: HWE
• UDI-Device Identifier: 00888867350571
• UDI-Public: 00888867350571
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2025

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: 3.0MM MGS DRILL BIT, STERILE
• Device Catalogue Number: AR-9628S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown