MAUDE Adverse Event Report: ARTHREX, INC. PEEK SWIVELOCK SP, 4.75X24.5MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	PEEK SWIVELOCK SP, 4.75X24.5MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during a rotator cuff repair shoulder arthroscopy/arthroscopic glenoid reconstruction surgery after the anchor was implanted, the threads broke when the guide was pulled out.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.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is confirmed.One unpackaged ar-2324pslm-1 self punching peek-swivelock was received for investigation.Visual evaluation of the returned device noted that the suture had torn as the ends were frayed.Functional testing was not able to be performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user error due to user-applied excessive mechanical forces.

• Brand Name: PEEK SWIVELOCK SP, 4.75X24.5MM
• 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: 20608755
• Report Number: 1220246-2024-08395
• Device Sequence Number: 20697663
• Product Code: MAI
• UDI-Device Identifier: 00888867098152
• UDI-Public: (01)00888867098152(11)220412(17)270331(10)14949766
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K151342
• 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): 02/03/2025

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 SWIVELOCK SP, 4.75X24.5MM
• Device Catalogue Number: AR-2324PSLM-1
• Device Lot Number: 14949766
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2022
• 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