MAUDE Adverse Event Report: ARTHREX, INC. GRAFTBOLT, TIBIAL 9MM; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number	GRAFTBOLT, TIBIAL 9MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/30/2022
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 2/20/2023,, it was reported by a distributor via email that an ar-5100-09 graftbolt sheath broke upon impact.This was discovered during a procedure on (b)(6) 2022.
Additional Manufacturer Narrative
Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error due to misaligned insertion and/or prying/leveraging during use.
Event or Problem Description
Additional information received on 2/23/2023: this was discovered during an acl procedure and completed using another ar-5100-09 graftbolt screw.All broken pieces were removed.

• Brand Name: GRAFTBOLT, TIBIAL 9MM
• Common Device Name: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• 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: 16528552
• Report Number: 1220246-2023-06409
• Device Sequence Number: 5246225
• Product Code: MBI
• UDI-Device Identifier: 00888867035768
• UDI-Public: 00888867035768
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K093912
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2024

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 Expiration Date: 04/30/2026
• Device Model Number: GRAFTBOLT, TIBIAL 9MM
• Device Catalogue Number: AR-5100-09
• Device Lot Number: 13348501
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2023
• Supplement Date Received by Manufacturer: 02/23/2023
• Initial Report FDA Received Date: 03/13/2023
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown