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	07/08/2024
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 4th september 2024, it was reported by an arthrex employee via email that for an ar-5100-08, graftbolt®, tibial, 8 mm, the sheath broke during insertion.This was detected during use in an anterior cruciate ligament reconstruction surgery on (b)(6) 2024.The case was completed successfully using another new ar-5100-08 graftbolt.All fragments were retrieved from patient.There was no patient harm and no secondary procedure needed.Ar-5108 was used to prepare the bone socket.
Additional Manufacturer Narrative
Complaint allegation is confirmed.Upon visual inspection, it was noted that the sheath, graftbolt returned had broken.Functional testing was not performed due to the damage to the device.Per dfu-0173-eo rev 0 g 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: 20244680
• Report Number: 1220246-2024-07693
• Device Sequence Number: 17982740
• Product Code: MBI
• UDI-Device Identifier: 00888867035751
• UDI-Public: 00888867035751
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2025

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: 14971757
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2022
• 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