MAUDE Adverse Event Report: ARTHREX, INC. PEEK 4.75 MM KNOTLESS CORKSCREW, SL, #5; BIO SOFT TISSUE FIXATN FASTNR

Model Number	PEEK 4.75 MM KNOTLESS CORKSCREW, SL, #5
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the corkscrew anchor has a crack in the peek coating.It was noticed before the surgery.There was no harm for patient, operator or third party.There was no case involvement reported.No further information received.Update dw 05-mar-2024: further information were provided that the reported event was noticed during the implantation.
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
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.Upon visual inspection, it was noted that the peek corkscrew of the peek, knotless corkscrew suture anchor single loaded with #5 suture, 4.75 x 14 mm, ve5 had cracked.Functional testing was not performed due to the damage to the corkscrew.The method of bone preparation and the quality of the bone encountered were not provided.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation, misalignment insertion, and/or prying/leveraging of the device during insertion.

• Brand Name: PEEK 4.75 MM KNOTLESS CORKSCREW, SL, #5
• 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: 18885179
• Report Number: 1220246-2024-01421
• Device Sequence Number: 3088947
• Product Code: MAI
• UDI-Device Identifier: 00888867366114
• UDI-Public: 00888867366114
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K193157
• 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): 08/16/2024

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: PEEK 4.75 MM KNOTLESS CORKSCREW, SL, #5
• Device Catalogue Number: AR-1927KPS
• Device Lot Number: 15055379
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2024
• Supplement Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2023
• 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