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

Model Number	ANTEGRADE TARGETING MODULE
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2023
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 (b)(6) 2023, it was reported by a sales representative via sems-06023480 that an 1271-200 targeting module has a crack in the jig and the bolt that holds the jig is loose.When the nail is fully tightened onto the jig, there is no positive stop, which then creates the nail to begin rotating while the nail is attached.This was discovered during a case, with no adverse effects on the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 complaint is confirmed.One unpackaged 1271-200 batch 160669 was received for investigation.Visual evaluation found a crack closed to the nail connector; it was also noted that the bolt that connects the jib was lost.The reported condition is most likely caused by overstressing a device that is damaged naturally and inevitably as a result of normal wear or aging.

• 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: 17876840
• Report Number: 1220246-2023-08068
• Device Sequence Number: 4401293
• Product Code: LXH
• UDI-Device Identifier: 00848665034073
• UDI-Public: 00848665034073
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 10/17/2024

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: 160669
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2023
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 10/17/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown