MAUDE Adverse Event Report: ARTHREX, INC. INTSCRW RD DELTATPR W/DISP SHTH 7X28MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	INTSCRW RD DELTATPR W/DISP SHTH 7X28MM
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint confirmed, there is a crack running longitudinally from the proximal end for approximately 1 cm.The relevant critical dimensions met specifications.The cause of the event is undermined, however likely causes include prying/leveraging the device; shallow driver engagement depth.The most likely cause for the reported failure can be attributed to prying/leveraging the device during insertion or shallow driver engagement depth.
Event or Problem Description
It was reported that when the implant was set on the ar-5028p-07 driver the implant fractured.No adverse effect on the patient.

• Brand Name: INTSCRW RD DELTATPR W/DISP SHTH 7X28MM
• 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: 19267700
• Report Number: 1220246-2024-02947
• Device Sequence Number: 20678529
• Product Code: MAI
• UDI-Device Identifier: 00888867035362
• UDI-Public: 00888867035362
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K062466
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/08/2024

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 Expiration Date: 06/30/2025
• Device Model Number: INTSCRW RD DELTATPR W/DISP SHTH 7X28MM
• Device Catalogue Number: AR-5028P-07
• Device Lot Number: 11381694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2020
• 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