MAUDE Adverse Event Report: TRIMED DRILL 1.6, 95MM CANNULATED

Model Number	DRILL-1.6/095C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Sales rep reported on (b)(6) 2023 that when the surgeon was drilling into the patient's bone, the tip of drill-1.6/095c started to split.It was reported that the surgeon made it into just a small portion of the bone before noticing something did not seem right.It was also stated that the patient had good bone quality and the proper technique was being followed.The incident caused a 45-minute delay in surgery as the surgeon attempted to remove the drill bits, however they were imbedded in the scaphoid and they could not find them.The rep reported there are 4 pieces of the drill left in the patient which could lead to complications in the future if any of the pieces are outside of the scaphoid which could damage the surrounding soft tissue.X-rays and a picture were provided however the remainder of the drill was discarded.

• Brand Name: DRILL 1.6, 95MM CANNULATED
• Common Device Name: DRILL 1.6, 95MM CANNULATED
• 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: 17427172
• Report Number: 2031009-2023-00005
• Device Sequence Number: 5955205
• Product Code: HTW
• UDI-Device Identifier: 00842188109607
• UDI-Public: 00842188109607
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• 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): 07/31/2023

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-1.6/095C
• Device Catalogue Number: DRILL-1.6/095C
• 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: 07/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 22 YR
• Patient Sex: Male