MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH, PEEK, CS FT, TRI-PLAY, 4.75MM; BONE FIXATION SCREW/PLATE

Model Number	SUTR ANCH, PEEK, CS FT, TRI-PLAY, 4.75MM
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, it was reported by a facility representative via phone that an ar-2324bcc suturelock and ar-1927psf-475 corkscrew anchor were implanted on (b)(6) 2023.Patient returned to the facility with an infection on (b)(6) 2023.This has not been a revision scheduled as of (b)(6) 2023.
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
The device was not received for evaluation and no photo was provided; complaint not confirmed.The most likely probable cause of the event is attributed to a patient-specific event.

• Brand Name: SUTR ANCH, PEEK, CS FT, TRI-PLAY, 4.75MM
• Common Device Name: BONE FIXATION SCREW/PLATE
• 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: 17152385
• Report Number: 1220246-2023-06916
• Device Sequence Number: 5683546
• Product Code: HWC
• UDI-Device Identifier: 00888867238602
• UDI-Public: 00888867238602
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SUTR ANCH, PEEK, CS FT, TRI-PLAY, 4.75MM
• Device Catalogue Number: AR-1927PSF-475
• Device Lot Number: 15014461
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2023
• Supplement Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown