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	11/30/2023
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 1/2/2024, it was reported by an arthrex subsidiary employee via email that an ar-1588rt acl tightrope rt and an ar-5100-08 graftbolt broke as the surgeon was pulling on the tightrope.The case was completed using another ar-1588rt acl tightrope rt and an ar-5100-08 graftbolt.All the broken fragments were successfully removed.This was discovered during an aclr procedure on (b)(6) 2023.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged, graftbolt®, tibial, 8 mm, ar-5100-08, batch 14998666, was received for investigation.Upon visual evaluation, it was noted that the sheath graftbolt is bent/damaged.The bone quality encountered during the procedure was not provided.The most likely cause can be attributed misuse due to improper bone preparation; misaligned insertion; or prying/leveraging the screw during insertion.Dfu-0173-1; g; precautions 4-6; states the following: "the graftbolt should always be inserted over a guidewire to ensure co-linear application of the sheath and screw.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.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.".

• 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: 18553250
• Report Number: 1220246-2024-00457
• Device Sequence Number: 17759659
• 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): 08/27/2024

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 Model Number: GRAFTBOLT, TIBIAL 8MM
• Device Catalogue Number: AR-5100-08
• Device Lot Number: 14998666
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2024
• Supplement Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 01/22/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2022
• 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