MAUDE Adverse Event Report: OSTEOMED, LLC 1.3MM PILOT DRILL OSTEOPOWER,12MM; HANDPIECE, ROTARY BONE CUTTING

Model Number	220-0302
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
To date, the device has not returned for evaluation, the root cause could not be established.Additional reporting on this event will be provided as a follow up report if more information becomes available.
Event or Problem Description
It was reported that during surgery, a 220-0302 drill bit broke, and part of it remained inside the patient, which could not be removed.

• Brand Name: 1.3MM PILOT DRILL OSTEOPOWER,12MM
• Common Device Name: HANDPIECE, ROTARY BONE CUTTING
• Manufacturer (Section D): OSTEOMED, LLC; 3885 arapaho rd; addison TX 75001
• Manufacturer (Section G): OSTEOMED, LLC; 3885 arapaho rd; addison TX 75001
• Manufacturer Contact: kimberly banning ; 3885 arapaho rd; addison, TX 75001
• MDR Report Key: 23526030
• Report Number: 2027754-2025-00053
• Device Sequence Number: 10167930
• Product Code: KMW
• UDI-Device Identifier: 00845694006408
• UDI-Public: 00845694006408
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K971692
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/11/2025

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: 220-0302
• Device Catalogue Number: 220-0302
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown