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

Model Number	ARCH, RETROGRADE TARGETING GUIDE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 4/19/2024, it was reported by a sales representative via (b)(4) that a 1281-000 arch, retrograde targeting guide broke at the retrograde femoral nail jig arm part during a case (photo is attached).The case was completed successfully using a synthes nail, with no pieces breaking inside the patient or delay in the case.This was discovered during a distal femur fracture procedure on (b)(4) 2024, with no reported 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 confirmed.One unpackaged 1281-000 batch 140629 was received for evaluation.Upon visual inspection, it was noted that a fragment of the black material had broken away, revealing the connector pin.The device also showed signs of wear and tear.Functional testing was not performed due to the damage to the device.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: ARCH, 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: jared engle ; 8009337001
• MDR Report Key: 19330126
• Report Number: 1220246-2024-03380
• Device Sequence Number: 3009577
• Product Code: HSB
• UDI-Device Identifier: 00848665017045
• UDI-Public: 00848665017045
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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): 09/12/2024

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: ARCH, RETROGRADE TARGETING GUIDE
• Device Catalogue Number: 1281-000
• Device Lot Number: 140629
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2024
• Supplement Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 09/12/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown