MAUDE Adverse Event Report: ARTHREX, INC. GRAFTBOLT, TIBIAL 9MM; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number	GRAFTBOLT, TIBIAL 9MM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2021
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.
Event or Problem Description
It was reported that during a procedure, when the surgeon was inserting the tibial graftbolt, ar-5100-09, the sheath of the screw broke up.The screw was removed from the patient and the case was completed with a second tibial graftbolt.No adverse effect to the patient.
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation identified that the sheath had fractured and is warp.The associated screw still attached to the sheath.Visual evaluation on the screw, did not showed any damaged or deformations.The most likely causes are improper bone prep, misaligned insertion, prying and/or leveraging the device.

• Brand Name: GRAFTBOLT, TIBIAL 9MM
• Common Device Name: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11259300
• Report Number: 1220246-2021-02530
• Device Sequence Number: 4188555
• Product Code: MBI
• UDI-Device Identifier: 00888867035768
• UDI-Public: 00888867035768
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K103060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Model Number: GRAFTBOLT, TIBIAL 9MM
• Device Catalogue Number: AR-5100-09
• Device Lot Number: 10413933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Initial Date Received by Manufacturer: 01/20/2021
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 02/01/2021
• Supplement Report FDA Received Date: 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other