MAUDE Adverse Event Report: TRIMED, INC DRILL; DRILL-4.0/220C

Model Number	DRILL-4.0/220C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/13/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The drill was inserted over k wire and was used to drill beyond the fracture location, the distal tip of the drill broke.The part performed as expected prior to breakage.The surgeon was able to use multiple instruments to retrieve approximately 5 loose fragments from the medullary canal.All pieces of the part were extracted from the patient, with no complications reported to date.The product rep states "during the last conversation with the surgeon, there were no issues".

• Brand Name: DRILL
• Common Device Name: DRILL-4.0/220C
• Manufacturer (Section D): TRIMED, INC; 27533 avenue hopkins; santa clarita CA 91355
• MDR Report Key: 6788542
• Report Number: 2031009-2017-00020
• Device Sequence Number: 10797937
• Product Code: LXH
• UDI-Device Identifier: 00842188109676
• UDI-Public: 00842188109676
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 07/13/2017

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: No Information
• Device Model Number: DRILL-4.0/220C
• Device Catalogue Number: DRILL-4.0/220C
• Device Lot Number: 501595
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2017
• Initial Report FDA Received Date: 08/11/2017
• 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: Required Intervention
• Patient Age: 65 YR