MAUDE Adverse Event Report: ARTHREX, INC. RETROGRADE TARGETING GUIDE; INTRAMED FIXATN ROD AND ACCESS

Model Number	RETROGRADE TARGETING GUIDE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/21/2023
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 08/21/2023, it was reported by a sales representative via sems that a 1280-000 retrograde targeting guide broke.This occurred during a case.There was no additional information provided, additional information has been requested.
Additional Manufacturer Narrative
Complaint is confirmed.Visual evaluation noted that the pegs of the retrograde targeting guide were broken off.No pieces were returned for investigation.Functional testing was not performed due to the broken pegs of the device.The most likely cause of this condition is user error.

• Brand Name: RETROGRADE TARGETING GUIDE
• Common Device Name: INTRAMED FIXATN ROD AND ACCESS
• 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: emily shafer ; 8009337001
• MDR Report Key: 17775187
• Report Number: 1220246-2023-07949
• Device Sequence Number: 18014973
• Product Code: HSB
• UDI-Device Identifier: 00848665017038
• UDI-Public: 00848665017038
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K132005
• 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): 10/19/2023

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: RETROGRADE TARGETING GUIDE
• Device Catalogue Number: 1280-000
• Device Lot Number: 200004
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2023
• Supplement Date Received by Manufacturer: 08/21/2023
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown