MAUDE Adverse Event Report: ARTHREX, INC. GRAFTBOLT, TIBIAL 8MM; NON-DEGRADABLE FIXATN FASTENER

Model Number	GRAFTBOLT, TIBIAL 8MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation; no pictures were provided.The method of bone preparation employed during the procedure, as well as the bone quality encountered, was not provided.The most likely cause can be attributed to improper bone preparation or prying/leveraging the screw during insertion.
Event or Problem Description
On 2/20/2023, it was reported by a distributor via email that an ar-5100-08 graftbolt sheath broke upon impact.This was discovered during a procedure on (b)(6) 2022.Additional information received on 2/23/2023: this was discovered during an acl procedure and completed using another ar-5100-08 graftbolt screw.The sheath cracked on impact but did not break into pieces.

• Brand Name: GRAFTBOLT, TIBIAL 8MM
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: 18413369
• Report Number: 1220246-2023-09743
• Device Sequence Number: 8724385
• Product Code: MBI
• UDI-Device Identifier: 00888867035751
• UDI-Public: 00888867035751
• 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
• Report Date (Section B): 12/28/2023

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 Expiration Date: 04/30/2023
• Device Model Number: GRAFTBOLT, TIBIAL 8MM
• Device Catalogue Number: AR-5100-08
• Device Lot Number: 10210752
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2023
• Initial Report FDA Received Date: 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/10/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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