MAUDE Adverse Event Report: ARTHREX, INC. INTSCRW RD DELTATPR 11X28MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	INTSCRW RD DELTATPR 11X28MM
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, it was reported by a distributor via email that an ar-5028p-11 tapered peek interference screw was be able to be inserter due to the threads being deformed.This was discovered during a procedure on (b)(6) 2022.Additional information requested.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on (b)(6) 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The probable cause of the event could not be determined from the information available and without device evaluation.As no further investigation was able to be performed no change in harm was identified.The most likely cause for the reported failure can be attributed to user error of the device due to applying excessive mechanical forces upon insertion.This complaint will be included in trending per wi-000100100.

• Brand Name: INTSCRW RD DELTATPR 11X28MM
• 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: jared engle ; 8009337001
• MDR Report Key: 19230779
• Report Number: 1220246-2024-02713
• Device Sequence Number: 6980337
• Product Code: MAI
• UDI-Device Identifier: 00888867035409
• UDI-Public: 00888867035409
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K062466
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/02/2024

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: INTSCRW RD DELTATPR 11X28MM
• Device Catalogue Number: AR-5028P-11
• Device Lot Number: 14469994
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/04/2021
• 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