MAUDE Adverse Event Report: ARTHREX, INC. INTSCRW RD DELTATPR W/DISP SHTH 10X28MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	INTSCRW RD DELTATPR W/DISP SHTH 10X28MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation identified that the screw had been fractured.The most likely cause can be attributed to improper bone preparation or prying/leveraging the screw during insertion.
Event or Problem Description
On 08/23/2021, it was reported by a sales representative via e-mail that an ar-5028p-10 peek would not seat.The surgeon then removed the screw and when attempting to re-insert the same screw, the device cracked but did not separate from the device.This was discovered during use in a procedure on (b)(6) 2021.The case was completed with a new ar-5028p-10.

• Brand Name: INTSCRW RD DELTATPR W/DISP SHTH 10X28MM
• 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: emily shafer ; 8009337001
• MDR Report Key: 18410022
• Report Number: 1220246-2023-09704
• Device Sequence Number: 2658922
• Product Code: MAI
• UDI-Device Identifier: 00888867035393
• UDI-Public: 00888867035393
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K062466
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/28/2023

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: 01/31/2026
• Device Model Number: INTSCRW RD DELTATPR W/DISP SHTH 10X28MM
• Device Catalogue Number: AR-5028P-10
• Device Lot Number: 12691939
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/09/2021
• 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