MAUDE Adverse Event Report: ARTHREX, INC. GRAFTBOLT, TIBIAL 7MM; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number	GRAFTBOLT, TIBIAL 7MM
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-5100-07, 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
It was reported that the sheath broke.The reported event is confirmed upon investigation of the returned product.Visual evaluation identified that the sheath had fractured into several pieces.The associated screw was not returned for investigation.The patient health and bone quality was not reported.The root cause of the reported failure mode is undetermined.However, the most likely probable cause is applying excessive mechanical forces upon insertion.

• Brand Name: GRAFTBOLT, TIBIAL 7MM
• Common Device Name: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11259003
• Report Number: 1220246-2021-02524
• Device Sequence Number: 4228677
• Product Code: MBI
• UDI-Device Identifier: 00888867035744
• UDI-Public: 00888867035744
• 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): 03/10/2021

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: 10/31/2023
• Device Model Number: GRAFTBOLT, TIBIAL 7MM
• Device Catalogue Number: AR-5100-07
• Device Lot Number: 10251920
• Was Device Available for Evaluation?: Yes
• 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: 03/10/2021
• 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