MAUDE Adverse Event Report: ARTHREX, INC. DEPTH GUIDE, MINI; GAUGE, DEPTH

Model Number	DEPTH GUIDE, MINI
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2022 , it was reported by a sales representative via email that an ar-13120g-2 depth gauge broke during regular usage.This was discovered during an unspecified procedure on (b)(6) 2022.Additional information requested.
Additional Manufacturer Narrative
Visual inspection found the pin of the device is broken off and returned with device.Complaint was confirmed.

• Brand Name: DEPTH GUIDE, MINI
• Common Device Name: GAUGE, DEPTH
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 15093436
• Report Number: 1220246-2022-05287
• Device Sequence Number: 3897139
• Product Code: HTJ
• UDI-Device Identifier: 00888867007727
• UDI-Public: 00888867007727
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2022

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: DEPTH GUIDE, MINI
• Device Catalogue Number: AR-13120G-2
• Device Lot Number: 01154400
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2022
• Supplement Date Received by Manufacturer: 07/05/2022
• Initial Report FDA Received Date: 07/25/2022
• Supplement Report FDA Received Date: 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown