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

Model Number	GRAFTBOLT, TIBIAL 8MM
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, it was reported by an arthrex employee via email that an ar-5100-08 graftbolt sheath broke during insertion.This was discovered during a reconstruction of the posterior cruciate ligament.Case was completed using another ar-5100-08 graftbolt.
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.
Additional Manufacturer Narrative
Complaint is confirmed.Upon visual evaluation, it was noted the delta peek screw and the sheath graftbolt are damaged.It probably was caused by applying excessive leveraging force.However, the broken pieces were not returned.The cause remains undetermined.

• Brand Name: GRAFTBOLT, TIBIAL 8MM
• 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: 16050985
• Report Number: 1220246-2022-05963
• Device Sequence Number: 17741071
• 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): 03/10/2023

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 Model Number: GRAFTBOLT, TIBIAL 8MM
• Device Catalogue Number: AR-5100-08
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2022
• Supplement Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 12/27/2022
• Supplement Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown