MAUDE Adverse Event Report: ARTHREX, INC. RETROGRADE TARGETING GUIDE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	RETROGRADE TARGETING GUIDE
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 09/20/2022, it was reported by a sales representative via sems that a 1280-000 targeting guide teeth broke off.This occurred on (b)(6) 2022 during a retrograde femoral nail when the teeth broke off where it engages in the nail for insertion.There was no patient effect reported, and no additional information provided.
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.
Additional Manufacturer Narrative
Complaint confirmed.Upon visual inspection, it was noted that the teeth for attachment to the nail were broken off.The cause of this remains undetermined, however probable cause can be attributed to prying/leveraging forces.

• Brand Name: RETROGRADE TARGETING GUIDE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 15575508
• Report Number: 1220246-2022-05595
• Device Sequence Number: 12307078
• Product Code: LXH
• UDI-Device Identifier: 00848665017038
• UDI-Public: 00848665017038
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 12/28/2022

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
• Operator of Device: Health Professional
• Device Model Number: RETROGRADE TARGETING GUIDE
• Device Catalogue Number: 1280-000
• Device Lot Number: 190515
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2022
• Supplement Date Received by Manufacturer: 09/20/2022
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 12/28/2022
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown