MAUDE Adverse Event Report: TRIMED DRILLS; DRILL 1.8, 100MM CANNULATED SMOOTH

Model Number	DRILL-1.8/100C S
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The regional sales manger reported on 16nov2023 that a surgeon reports he had a 4th metacarpal case where he was using the drill-1.8/100 c s by hand and was not getting advancement, so he then put the drill on power.Once advanced on power, the drill broke in 2 areas.Drills are intended to be used under power.The surgeonh had to retrieve the pieces, which created a 30 minute delay in surgery.When he opened the patient further to get the broken drill, he then noticed a ruptured extensor tendon but he did not believe that the drill caused the tendon rupture.No additional harm was caused by the drill breaking.

• Brand Name: DRILLS
• Common Device Name: DRILL 1.8, 100MM CANNULATED SMOOTH
• 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
• MDR Report Key: 18248956
• Report Number: 2031009-2023-00008
• Device Sequence Number: 20475917
• Product Code: HTW
• UDI-Device Identifier: 00842188123870
• UDI-Public: 00842188123870
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/01/2023

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-1.8/100C S
• Device Catalogue Number: DRILL-1.8/100C S
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/01/2023
• 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: Required Intervention
• Patient Sex: Unknown