MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP SWIVELOCK SP, 5.5X24.5MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIO-COMP SWIVELOCK SP, 5.5X24.5MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	08/17/2023
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
On (b)(6) 2023, it was reported by a sales representative via email that an ar-2323bcm bio-composite swivelock sp broke during insertion.This was discovered during a procedure on (b)(6)2023.Additional information requested.
Event or Problem Description
Additional information received on 9/17/2024: this was discovered during an rcr procedure.After using the mallet to knock the anchor into the laser line, the anchor started to advance into the bone then the anchor split vertically down the middle.It was then stripped.The entire anchor was able to be pulled out.Nothing was left behind.The case was completed using an ar-2323bcm bio-composite swivelock sp.The bone was normal to soft quality.The surgeon had to use a bigger anchor medial because the bone quality wasn¿t very good.The case only delayed about thirty seconds.
Additional Manufacturer Narrative
Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely causes of the reported failure are improper bone preparation, misaligned insertion, and prying/leveraging the device during insertion.

• Brand Name: BIO-COMP SWIVELOCK SP, 5.5X24.5MM
• 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: 17731828
• Report Number: 1220246-2023-07862
• Device Sequence Number: 5820374
• Product Code: MAI
• UDI-Device Identifier: 00888867026735
• UDI-Public: 00888867026735
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K191226
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/25/2024

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: 10/31/2023
• Device Model Number: BIO-COMP SWIVELOCK SP, 5.5X24.5MM
• Device Catalogue Number: AR-2323BCM
• Device Lot Number: 10464486
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2023
• Supplement Date Received by Manufacturer: Not provided; 10/09/2024
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 10/01/2024; 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2019
• 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