MAUDE Adverse Event Report: TRIMED, INC CANNULATED COMPRESSION SCREW 3.0, 30MM; CANNULATED COMPRS SCREW 3.0, 30MM

Model Number	C3030
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/24/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Trimed was notified on march 2nd, 2018, by sales rep (b)(4), that a cannulated compression screw broke during surgery and a piece remained in the patient.This event happened at a medical facility in (b)(6) on (b)(6) 2018.This is the second time that breakage for the cannulated compression screw has been reported to trimed in the last five years.

• Brand Name: CANNULATED COMPRESSION SCREW 3.0, 30MM
• Common Device Name: CANNULATED COMPRS SCREW 3.0, 30MM
• Manufacturer (Section D): TRIMED, INC; 27533 avenue hopkins; santa clarita CA 91355
• MDR Report Key: 7386347
• Report Number: 2031009-2018-00019
• Device Sequence Number: 11020489
• Product Code: HWC
• UDI-Device Identifier: 00842188102165
• UDI-Public: 00842188102165
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K050681
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/02/2018

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: C3030
• Device Catalogue Number: C3030
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2018
• Initial Report FDA Received Date: 03/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1