MAUDE Adverse Event Report: TRIMED DRILL 1.8, 90MM

Model Number	DRILL-1.8/090
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A trimed sales rep reported on (b)(6) 2023 that a drill-1.8/090 broke inside a patient's radius.The surgeon decided it would be best to leave the broken piece of the drill in the patient and does not believe it will cause the patient any additional harm or irritation.The trimed sales rep reported that this did not cause a delay in surgery since it was the last hole to be drilled in order to complete the procedure.

• Brand Name: DRILL 1.8, 90MM
• Common Device Name: DRILL 1.8, 90MM
• Manufacturer (Section D): TRIMED; 27533 avenue hopkins; santa clarita CA 91355
• Manufacturer (Section G): TRIMED; 27533 avenue hopkins; santa clarita CA 91355
• Manufacturer Contact: megan rissler ; 27533 avenue hopkins; santa clarita, CA 91355 ; 6612557406
• MDR Report Key: 16656631
• Report Number: 2031009-2023-00003
• Device Sequence Number: 15263240
• Product Code: HTW
• UDI-Device Identifier: 00842188109492
• UDI-Public: 00842188109492
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/31/2023

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-1.8/090
• Device Catalogue Number: DRILL-1.8/090
• Device Lot Number: AC21017
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown