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

Model Number	ANTEGRADE TARGETING MODULE
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via (b)(46.That a 1271-300 antegrade targeting module had an issue with the screw sheath being loose on the jig and therefore missing the nail implant.This was discovered during an unspecified procedure, with no reported adverse event or patient harm.
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 allegation is not confirmed.One unpackaged 1271-300 antegrade targeting module batch number: 213098 was returned for investigation.Visual evaluation noted no problems with the device.Functional testing was performed with an 0624-000 screw sheath batch number: 201243 by placing the screw sheath through the appropriate transverse hole in the targeting guide.It was noted that the screw sheath fit well within the 1271-300 antegrade targeting module and was not loose at all.No problem found.

• Brand Name: ANTEGRADE TARGETING MODULE
• 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: 18419657
• Report Number: 1220246-2023-09775
• Device Sequence Number: 7964586
• Product Code: LXH
• UDI-Device Identifier: 00848665034073
• UDI-Public: 00848665034073
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/14/2024

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: ANTEGRADE TARGETING MODULE
• Device Catalogue Number: 1271-300
• Device Lot Number: 213098
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2023
• Supplement Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 12/29/2023
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown