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 Codes	Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	08/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 8/28/2023, it was reported by an arthrex subsidiary employee via email that an ar-2324pslm peek-swivelock sp anchor deformed upon insertion.This was discovered during a procedure on (b)(6) 2023.Additional information received on 9/8/2023: this was discovered during a shoulder arthroscopy procedure.The anchor never broke but deformed when it touched bone during insertion.The case was completed using an ar-2324bcc biocomposite swivelock c.The case was delayed around five minutes.
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, h6.The complaint allegation was confirmed.The failed device was not received for evaluation.Upon evaluating the customer's attached picture, it was noted that the anchor was damaged at the distal end at the tip.The anchor geometry was lost and deformed, most likely as a result of excessive pressure.The bone quality encountered, was described as a hard.The most likely cause for the reported failure is a user error.Per dfu-0087 at revision 0.G.Precautions.7.Self-punching suture anchors only: insertion in very hard bone may require pre-punching a bone socket to avoid damage to the implant.8.Self-punching pushlock and swivelock suture anchors only: ensure that the angle of anchor insertion is perpendicular to the bone.

• 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: emily shafer ; 8009337001
• MDR Report Key: 17782526
• Report Number: 1220246-2023-07960
• Device Sequence Number: 5838460
• Product Code: MAI
• UDI-Device Identifier: 00888867026926
• UDI-Public: 00888867026926
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K191226
• 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): 07/05/2024

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 SWIVELOCK SP, 4.75X24.5MM
• Device Catalogue Number: AR-2324PSLM
• Device Lot Number: 14996859
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2023
• Supplement Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 09/20/2023
• Supplement Report FDA Received Date: 07/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/30/2022
• 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