MAUDE Adverse Event Report: TRIMED, INC DRILL; DRILL-1.6/095

Model Number	DRILL-1.6/095
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/29/2017
Type of Reportable Event	Malfunction
Event or Problem Description
During surgery on (b)(6) 2017, a surgeon inserted drill-1.6/095 (lot#196758) over a bent k-wire, and the drill split open at the bend in k-wire, outside the bone.The drill and k-wire were removed, and the rep confirmed that there were no broken pieces or debris created from the drill splitting.This is the first occurrence of this kind for this type of product.

• Brand Name: DRILL
• Common Device Name: DRILL-1.6/095
• Manufacturer (Section D): TRIMED, INC; 27533 avenue hopkins; santa clarita CA 91355
• MDR Report Key: 7260133
• Report Number: 2031009-2018-00005
• Device Sequence Number: 882663
• Product Code: LXH
• UDI-Device Identifier: 00842188109607
• UDI-Public: 00842188109607
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/15/2018

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-1.6/095
• Device Catalogue Number: DRILL-1.6/095
• Device Lot Number: 196758
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2018
• Initial Report FDA Received Date: 02/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 68