MAUDE Adverse Event Report: TRIMED, INC TORX CORTICAL SCREW; TRX2.3-16

Model Number	TRX3.2-16
Medical Device Problem Code	Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/09/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During surgery on (b)(6) 2018, a trx2.3-16 (lot #92820) screw was found to have blood on it.A tech discovered the screw had blood on it and immediately removed the screw from the sterile field.The patient was saved from any cross contamination.This is the first occurrence of this kind for this type of product.

• Brand Name: TORX CORTICAL SCREW
• Common Device Name: TRX2.3-16
• Manufacturer (Section D): TRIMED, INC; 27533 avenue hopkins; santa clarita CA 91355
• MDR Report Key: 7260127
• Report Number: 2031009-2018-00006
• Device Sequence Number: 1158096
• Product Code: HWC
• UDI-Device Identifier: 00842188108624
• UDI-Public: 00842188108624
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K951302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• 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: TRX3.2-16
• Device Catalogue Number: TRX3.2-16
• Device Lot Number: 92820
• 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: 01/10/2018
• 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