MAUDE Adverse Event Report: ARTHREX, INC. SCREW CAPTURING ROD, STRAIGHT HANDLE; INTRAMED FIXATN ROD AND ACCESS

Model Number	SCREW CAPTURING ROD, STRAIGHT HANDLE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 04/05/2024, it was reported by a sales representative via (b)(4) that a lag screw capturing rod (5033-100) and a lag screw capturing rod nut (5046-100) were broken.The tip of the rod was broken off within the nut and was unusable.This must have happened in a previous case.However, during the case, the screw capturing rod, long for the straight handle (0477-000) broke while the surgeon was using it.No additional information was provided, and additional information has been asked.
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.Upon visual inspection, it was determined that the rod of the lag screw was broken off.No broken parts were returned for investigation.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: SCREW CAPTURING ROD, STRAIGHT HANDLE
• 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: 19214450
• Report Number: 1220246-2024-02630
• Device Sequence Number: 7025685
• Product Code: HSB
• UDI-Device Identifier: 00848665002034
• UDI-Public: 00848665002034
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K021008
• 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): 08/19/2024

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: SCREW CAPTURING ROD, STRAIGHT HANDLE
• Device Catalogue Number: 0477-000
• Device Lot Number: 212447
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2024
• Supplement Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2021
• 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