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

Model Number	DEPTH GUIDE, MINI
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/18/2024
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 01/18/2024, it was reported by a sales representative via (b)(4) that an ar-13120g-2 depth guide mini tip broke off.This occurred during a distal radius fracture when the surgeon was placing his distal row of screws with 2.4 variable locking screws.After drilling for the 3rd distal screw, the gold drill sleeve was removed, and the surgeon inserted the depth gauge for the 2.4 screws (ar-13120g-2) into the plate and through the drill hole.The surgeon then tried to get a measurement, and the tip of the depth gauge broke off into the patient.The broken fragments was retrieved from the patient.No additional information was provided, and additional information has been asked.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint confirmed.One unpackaged ar-13120g-2 depth guide mini was received for evaluation.Upon visual inspection, it was noted that the instrument needle was broken off and bent at the proximal end.No functional test was performed for the instrument due to the damage.The most likely cause is misuse due to user error of using excessive force to pry and leverage the device.

• Brand Name: DEPTH GUIDE, MINI
• Common Device Name: DEPTH GAUGE
• 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: jared engle ; 8009337001
• MDR Report Key: 18669128
• Report Number: 1220246-2024-00853
• Device Sequence Number: 17966329
• Product Code: HTJ
• UDI-Device Identifier: 00888867007727
• UDI-Public: 00888867007727
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 11/27/2024

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: DEPTH GUIDE, MINI
• Device Catalogue Number: AR-13120G-2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2024
• Supplement Date Received by Manufacturer: 11/27/2024
• Initial Report FDA Received Date: 02/08/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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