MAUDE Adverse Event Report: ARTHREX, INC. SCREW CAPTURING ROD, T-HANDLE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	SCREW CAPTURING ROD, T-HANDLE
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/21/2022
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 11/21/2022, it was reported by a sales representative via sems that a 0476-000 screw capturing rod broke.This occurred during a case, there was no additional information provided.Additional information requested.
Additional Manufacturer Narrative
Additional information: h6.The complaint cannot be confirmed without the return of the device for evaluation.Event description: a 0476-000 screw capturing rod broke.The most likely cause(s) of this type of event include applying excessive forces through leveraging/prying the device.

• Brand Name: SCREW CAPTURING ROD, T-HANDLE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: vik bajnath ; 8009337001
• MDR Report Key: 15931153
• Report Number: 1220246-2022-05897
• Device Sequence Number: 15134168
• Product Code: HSB
• UDI-Device Identifier: 00848665002027
• UDI-Public: 00848665002027
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 10/27/2023

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, T-HANDLE
• Device Catalogue Number: 0476-000
• Device Lot Number: 121446
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2022
• Supplement Date Received by Manufacturer: 11/21/2022
• Initial Report FDA Received Date: 12/07/2022
• Supplement Report FDA Received Date: 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown