MAUDE Adverse Event Report: ARTHREX, INC. Ø10X 30MM BC IF SCRW, VENTED; BIO SOFT TISSUE FIXATN FASTNR

Model Number	Ø10X 30MM BC IF SCRW, VENTED
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via phone that an ar-4030c-09 interference screw, and a ar-4030c-10 interference screw broke.This occurred during an acl procedure on (b)(6) 2023 while screwing the ar-4030c-09 in it cracked and broke into 2, there was a 5-minute delay in retrieving the fragments and grabbing the ar-4030c-10.While screwing the ar-4030c-10 the same issue occurred it cracked and broke into 2, there was another 5-minute delay in retrieving the fragments and grabbing the 10x28 screw to complete the case.The patient had pretty good bone quality, and a 9mm reamer was used to prepare the bone socket for insertion.
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
Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause can be attributed misuse due to misaligned insertion; or prying/leveraging the screw during insertion.

• Brand Name: Ø10X 30MM BC IF SCRW, VENTED
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: 17565325
• Report Number: 1220246-2023-07532
• Device Sequence Number: 6665677
• Product Code: MAI
• UDI-Device Identifier: 00888867277670
• UDI-Public: 00888867277670
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K180662
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2025

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: Ø10X 30MM BC IF SCRW, VENTED
• Device Catalogue Number: AR-4030C-10
• Device Lot Number: 15020239
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2023
• Supplement Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 08/17/2023
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2022
• 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