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

Model Number	TARGETING MODULE
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 04/18/2025, it was reported by a sales representative via (b)(4) that a 1238-100 targeting module jig cracked.This was discovered during the case with no patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged 1238-100 batch 212568 was received for investigation.Functional testing was not performed.The device was received broken.Visual inspection found that the device has a crack on the connector.The most likely reason for the reported failure is the wear and tear damage incurred over repeated usage.The device manufacturing date is 2021.The complaint allegation was confirmed.Refer to the investigation pictures.

• Brand Name: 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: jared engle ; 8009337001
• MDR Report Key: 22017908
• Report Number: 1220246-2025-02038
• Device Sequence Number: 9530487
• Product Code: HSB
• UDI-Device Identifier: 00848665006049
• UDI-Public: (01)00848665006049(11)210825(10)212568
• 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): 08/23/2025

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: TARGETING MODULE
• Device Catalogue Number: 1238-100
• Device Lot Number: 212568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 08/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2021
• 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