MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH, DX SWVLK, PEEK, 1/PK, 4.75 MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SUTR ANCH, DX SWVLK, PEEK, 1/PK, 4.75 MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an arthroscopic suturing of the meniscus the screw of the device broke while tightening into the pre-drilled channel.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.Update avoe 09-oct-2023: it was confirmed that all fragments were retrieved from the patient.
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 complaint allegation is confirmed.One unpackaged ar-89080p-1, batch 12082757, was received for investigation.Upon visual inspection, it was noted that the eyelet was damaged, and the screw was broken.The method used to prepare the bone as well as the bone quality encountered were not provided.The most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: SUTR ANCH, DX SWVLK, PEEK, 1/PK, 4.75 MM
• 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: 17997187
• Report Number: 1220246-2023-08346
• Device Sequence Number: 5830926
• Product Code: MAI
• UDI-Device Identifier: 00888867319912
• UDI-Public: 00888867319912
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K101823
• 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): 07/03/2024

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: 10/31/2025
• Device Model Number: SUTR ANCH, DX SWVLK, PEEK, 1/PK, 4.75 MM
• Device Catalogue Number: AR-8980P-1
• Device Lot Number: 12082757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2023
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2020
• 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