MAUDE Adverse Event Report: TRIMED, INC HEX DRIVER 2.5MM AO

Model Number	HXDRIVR-2.5AO
Medical Device Problem Code	Residue After Decontamination (2325)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2017
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2017 it was reported to a trimed customer service representative, that four 2.5 ao hex driver's epoxy had bled after sterilizing the tray.This is the third occurence of this type of complaint this year.

• Brand Name: HEX DRIVER 2.5MM AO
• Common Device Name: HEX DRIVER
• Manufacturer (Section D): TRIMED, INC; 27533 avenue hopkins; santa clarita, ca
• Manufacturer (Section G): QUADM TECHNOLOGIES; 7 marlen drive; suite 7e; hamilton, nj
• Manufacturer Contact: michael capellan ; 27533 avenue hopkins; santa clarita, ca ; 6337221
• MDR Report Key: 7105708
• Report Number: 2031009-2017-00030
• Device Sequence Number: 2864600
• Product Code: HWC
• UDI-Device Identifier: 00842188112621
• UDI-Public: 00842188112621
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2017

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
• Device Model Number: HXDRIVR-2.5AO
• Device Catalogue Number: HXDRIVR-2.5 AO
• Device Lot Number: 91957, 92238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2017
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2017
• Supplement Date Received by Manufacturer: 10/23/2017
• Initial Report FDA Received Date: 12/11/2017
• Supplement Report FDA Received Date: 12/11/2017
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown