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

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	07/27/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Trimed received the following report on (b)(6) 2018 from trimed sales member located in the united states, regarding the drill 4.0, 220mm cannulated: during an intra-operative procedure, it was discovered that the drill 4.0, 220mm cannulated (drill-4.0/220c) had malfunctioned.The surgeon used a replacement drill which had the same outcome.The surgeon then used a third drill to successfully complete the surgery.This incident did not cause any further harm to the patient.This is the first time this type of malfunction has been reported, for the drill-4.0/220c, to trimed.
Additional Manufacturer Narrative
Testing was completed for drills from the same lot and the actual device was evaluated.

• Brand Name: DRILL 4.0, 220MM CANNULATED
• Common Device Name: DRILL 4.0, 220MM CANNULATED
• Manufacturer (Section D): TRIMED, INC.; 27533 avenue hopkins; santa clarita CA 91355
• MDR Report Key: 7838819
• Report Number: 2031009-2018-00050
• Device Sequence Number: 1175189
• Product Code: LXH
• UDI-Device Identifier: 00842188109676
• UDI-Public: 00842188109676
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2018

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-4.0/220C
• Device Catalogue Number: DRILL-4.0/220C
• Device Lot Number: 000878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/31/2018
• Supplement Report FDA Received Date: 10/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1