MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMPR INTERF SCRW,FULL THD; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	BIO-COMPR INTERF SCRW,FULL THD
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, it was reported by a distributor via email that an ar-1400tc full thread cannulated biocomposite interference screw goes in well into the tunnel; however, when removing the screwdriver, the screw came out with it, damaged, and was not able to use again.This was discovered during a procedure on (b)(6) 2022.
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.

• Brand Name: BIO-COMPR INTERF SCRW,FULL THD
• 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: 13393090
• Report Number: 1220246-2022-04338
• Device Sequence Number: 19956860
• Product Code: MAI
• UDI-Device Identifier: 00888867016231
• UDI-Public: 00888867016231
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K071176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/31/2022

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: 03/31/2024
• Device Model Number: BIO-COMPR INTERF SCRW,FULL THD
• Device Catalogue Number: AR-1400TC
• Device Lot Number: 10899561
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2022
• Initial Report FDA Received Date: 01/31/2022
• Date Device Manufactured: 04/29/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown