MAUDE Adverse Event Report: ARTHREX, INC. Ø10X 30MM BC IF SCRW, VENTED; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	Ø10X 30MM BC IF SCRW, VENTED
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 9/7/2022, it was reported by a sales representative via phone that an ar-4030c-10 fastthread¿ biocomposite¿ interference screw 10 x 30 mm had an issue.During an acl reconstruction procedure on (b)(6) 2022 during a soft tissue allograft, when the surgeon tried to insert the screw, he almost got all the way through, but then had to back the screw out and noticed that part of the thread of the screw had broken off inside the patient.He was able to remove the fragment, the broken thread, and the screw, and used another ar-4030c-10 fastthread¿ biocomposite¿ interference screw 10 x 30 mm, lot number unknown, to complete the case successfully with no impact to the patient.The complaint device has been discarded, but a picture was taken of the broken complaint device before it was discarded, and was provided via email.
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
Review of this complaint confirmed the event summary code selection and an investigation including a product history review was performed as required.The complaint device was not returned for investigation, however, picture(s) of the complaint device were provided and used for investigation.The investigation confirmed the reported condition.The probable cause of the event was not able to be determined.The investigation did not change the potential harm(s) identified.Complaint trending for this event will be performed per wi-000100100.

• Brand Name: Ø10X 30MM 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: 15484161
• Report Number: 1220246-2022-05522
• Device Sequence Number: 20772329
• Product Code: MAI
• UDI-Device Identifier: 00888867277670
• UDI-Public: 00888867277670
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 12/29/2022

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: 10/31/2025
• Device Model Number: Ø10X 30MM BC IF SCRW, VENTED
• Device Catalogue Number: AR-4030C-10
• Device Lot Number: 14462999
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2022
• Supplement Date Received by Manufacturer: 09/07/2022
• Initial Report FDA Received Date: 09/26/2022
• Supplement Report FDA Received Date: 12/29/2022
• Date Device Manufactured: 11/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown