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

Model Number	SUTR ANCH,PEEK CRKSCRW FT,TRI-PLAY
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the anchor broke while it was inserted.No further information received.
Additional Manufacturer Narrative
Additional info: b5 event updated.G3 follow-up information received.H6 update.Complaint is confirmed.Functional testing was not performed on the returned ar-1927psf-3 due to the damage to the anchor of the device.Visual evaluation noted that the tip of the anchor is broken off and was not returned.The most likely cause is attributed to misuse due to prying/leveraging the device during use.Refer to investigation photos.
Event or Problem Description
Update avoe 25-sep-2023.Further information was provided that the error occurred on the 17.5.2023 during a rotator knotted repair surgery.All fragments were retrieved from the patient.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: SUTR ANCH,PEEK CRKSCRW FT,TRI-PLAY
• 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: 17413953
• Report Number: 1220246-2023-07339
• Device Sequence Number: 12546457
• Product Code: MBI
• UDI-Device Identifier: 00888867023642
• UDI-Public: 00888867023642
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K143745
• 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,Followup
• Report Date (Section B): 02/29/2024

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: SUTR ANCH,PEEK CRKSCRW FT,TRI-PLAY
• Device Catalogue Number: AR-1927PSF-3
• Device Lot Number: 15034749
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2023
• Supplement Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 07/28/2023
• Supplement Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2022
• 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