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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 24th december 2024, it was reported by an arthrex employee via email that for an ar-5100-08, graftbolt®, tibial, 8 mm, the anchor broke during insertion.This was detected during an anterior cruciate ligament reconstruction surgery on (b)(6) 2024.Ar-5108 was used to prepare the bone socket.The anchor broke during insertion and no fragments were left in the patient.Procedure was successfully completed with no patient harm and no secondary procedure needed by using another new ar-5100-08.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.One unpackaged, ar-5100-08, graftbolt®, tibial, 8 mm, batch: 15214592, was received for investigation.Functional testing was not performed due to the damage to the device.Upon visual evaluation, it was noted that the sheath was broken/disfigured.The most likely cause can be attributed misuse due to misaligned insertion; or prying/leveraging the screw during insertion.Per dfu-0173-eo rev 0; precautions: "5.Do not apply excessive impaction forces to the graftbolt upon insertion into the tibia, as this may cause damage to the implant.If there is difficulty upon insertion, remove the device and redilate the tunnel.6.Do not apply excessive torsional forces to the screw upon insertion into the sheath.Caution: failure to fully seat the screwdriver in the screw socket or malalignment between the screwdriver and screw socket may result in damage to the screwdriver or the implant.The most likely cause for the reported failure can be attributed to user error of the device due to applying excessive mechanical forces upon insertion.".

• 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: jared engle ; 8009337001
• MDR Report Key: 21149698
• Report Number: 1220246-2025-09444
• Device Sequence Number: 9088720
• Product Code: MBI
• UDI-Device Identifier: 00888867035751
• UDI-Public: (01)00888867035751(11)240301(17)290228(10)15214592
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2025

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: GRAFTBOLT, TIBIAL 8MM
• Device Catalogue Number: AR-5100-08
• Device Lot Number: 15214592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2024
• Supplement Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2024
• 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