MAUDE Adverse Event Report: TRIMED, INC GAUGE-1.6/2.0, TOOLS - HPS; DEPTH GAUGE, 1.6MM/2.0MM

Model Number	GAUGE-1.6/2.0
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/15/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The individual utilizing the gauge-1.6/2.0 was having reassembly issues post cleaning and autoclave process.In addition to this complaint, it was difficult for the surgeon to feel the far cortex with the hook of the gauge according to the sales representative involved in the case.

• Brand Name: GAUGE-1.6/2.0, TOOLS - HPS
• Common Device Name: DEPTH GAUGE, 1.6MM/2.0MM
• Manufacturer (Section D): TRIMED, INC; 27533 avenue hopkins; santa clarita CA 91355
• MDR Report Key: 7223515
• Report Number: 2031009-2018-00004
• Device Sequence Number: 918396
• Product Code: LXH
• UDI-Device Identifier: 00842188111815
• UDI-Public: 00842188111815
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/19/2017

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
• Operator of Device: Health Professional
• Device Model Number: GAUGE-1.6/2.0
• Device Catalogue Number: GAUGE-1.6/2.0
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2017
• Initial Report FDA Received Date: 01/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1