MAUDE Adverse Event Report: ARTHREX, INC. Ø10X 20MM BC IF SCRW, VENTED; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	Ø10X 20MM BC IF SCRW, VENTED
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/01/2022
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 (b)(6) 2022, it was reported by a sales representative via phone that an ar-4020c-10 fastthread biocomposite interference screw broke in half as it was getting inserted.Initially the surgeon was having trouble loading the driver on the screw, as it was not seating properly, eventually surgeon was able to screw in it when it broke.Everything was retrieved from the patient and case was completed with another ar-4020c-10 screw without further issues.This was discovered during an acl reconstruction with patella allograft procedure on (b)(6) 2022.
Additional Manufacturer Narrative
Complaint allegation was not confirmed.The complaint device was not returned for evaluation.Instead, a seal packaged interference screw sheath component of set was returned for evaluation.No damaged was observed to the returned device.

• Brand Name: Ø10X 20MM BC IF SCRW, VENTED
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, 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: 14136560
• Report Number: 1220246-2022-04753
• Device Sequence Number: 4909356
• Product Code: MAI
• UDI-Device Identifier: 00888867276987
• UDI-Public: 00888867276987
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 07/18/2022

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 Expiration Date: 02/28/2025
• Device Model Number: Ø10X 20MM BC IF SCRW, VENTED
• Device Catalogue Number: AR-4020C-10
• Device Lot Number: 12942653
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2022
• Supplement Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 04/18/2022
• Supplement Report FDA Received Date: 07/18/2022
• Date Device Manufactured: 03/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown