MAUDE Adverse Event Report: MEDARTIS INC PROVISION; BIT, DRILL

Model Number	A-3230
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Patient went to the operating room for a orif [open reduction and internal fixation], right metacarpal fracture.Medartis kit was used for implants.During the procedure four different drill bits broke and became stuck inside the patient.Surgeon was able to remove two of them, however two pieces of drill bit remained in the bone.

• Brand Name: PROVISION
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): MEDARTIS INC; 1195 polk drive; warsaw IN 46582
• MDR Report Key: 22166379
• Report Number: 22166379
• Device Sequence Number: 7829220
• Product Code: HTW
• UDI-Device Identifier: 00810041061737
• UDI-Public: 00810041061737
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/05/2025
• Report Date (Section F): 06/05/2025

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: A-3230
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/09/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/09/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Sex: Female
• Date Report Sent to FDA: 06/05/2025