MAUDE Adverse Event Report: TRIMED INC. HEX DRIVER 2.5MM AO; HEX DRIVER 3.5 AO; HEX DRIVERS

Model Number	HXDRIVR-2.5 AO; HXDRIVR3.5 AO
Medical Device Problem Code	Residue After Decontamination (2325)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/15/2017
Type of Reportable Event	Malfunction
Event or Problem Description
A hxdrivr-2.5 ao and hxdrivr-3.5 ao were flashed in an autoclave in central sterile due to a hole in the sterile wrapping.The scrub tech noticed upon opening the tray for post-sterilization inspection, that both drivers had epoxy coming off after sterilization.The tray was a loaner tray, the surgeon stated that this incident was not an issue for them as the drivers were not used in surgery and they felt that this incident did not negatively affect the patient's health or delay surgery.

• Brand Name: HEX DRIVER 2.5MM AO; HEX DRIVER 3.5 AO
• Common Device Name: HEX DRIVERS
• 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: 7105706
• Report Number: 2031009-2017-00006
• Device Sequence Number: 2526609
• Product Code: HWR
• UDI-Device Identifier: 00842188112621
• UDI-Public: 00842188112621
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2017

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-2.5 AO; HXDRIVR3.5 AO
• Device Catalogue Number: HXDRIVR-2.5 AO; HXDRIVR3.5 AO
• Device Lot Number: 92238; 91857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2017
• Supplement Date Received by Manufacturer: 02/14/2017
• Initial Report FDA Received Date: 12/11/2017
• Supplement Report FDA Received Date: 12/11/2017
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown