MAUDE Adverse Event Report: ARTHREX, INC. 1.6MM FIBER TAK SHAVERDRILL; POWERED SURG ORTHOPEDIC INSTR

Model Number	1.6MM FIBER TAK SHAVERDRILL
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	07/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a surgery, the post-operative x-ray showed a drill tip still remaining in the patient, which wasn¿t realised during the operation.An additional surgery was required to remove the broken drill tip.Per complaint reporter there was no harm for patient, operator or third party.***update c mackenbach 20-aug*** additional information was provided that the original surgery date was a latarjet procedure on (b)(6) -2025 and the revision surgery date was on (b)(6) 2025.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: 1.6MM FIBER TAK SHAVERDRILL
• 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: 22924328
• Report Number: 1220246-2025-03684
• Device Sequence Number: 10230791
• Product Code: HWE
• UDI-Device Identifier: 00888867239463
• UDI-Public: (01)00888867239463(11)240603(17)290531(10)15256805
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 08/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1.6MM FIBER TAK SHAVERDRILL
• Device Catalogue Number: AR-3600NDSR-1
• Device Lot Number: 15256805
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown