MAUDE Adverse Event Report: TRIMED, INC. DRILL 4.0, 220 MM CANNULATED; DRILL 4.0, 220 CANNULATED

Model Number	DRILL-4.0CL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Trimed received the following report on 03 jul 2018 from trimed sales member located in the (b)(4), regarding the drill 4.0, 220 mm cannulated: during a intra-operative procedure, it was discovered that the drill 4.0, 220 mm cannulated (drill-4.0 cl) had malfunctioned once it made contact with the bone.The bone quality was determined to be quite sclerotic compared to usual.This incident did not cause any further harm to the patient.This is the first time this type of malfunction has been reported to trimed.
Additional Manufacturer Narrative
It was determined that this should be reported as "serious injury" instead of malfunction.

• Brand Name: DRILL 4.0, 220 MM CANNULATED
• Common Device Name: DRILL 4.0, 220 CANNULATED
• Manufacturer (Section D): TRIMED, INC.; 27533 avenue hopkins; santa clarita CA 91355
• MDR Report Key: 7742605
• Report Number: 2031009-2018-00046
• Device Sequence Number: 16495014
• Product Code: LXH
• UDI-Device Identifier: 00842188109881
• UDI-Public: 00842188109881
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2018

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-4.0CL
• Device Catalogue Number: DRILL-4.0CL
• Device Lot Number: 000878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2018
• Initial Date Received by Manufacturer: 07/03/2018
• Supplement Date Received by Manufacturer: 07/03/2018
• Initial Report FDA Received Date: 08/02/2018
• Supplement Report FDA Received Date: 10/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1