MAUDE Adverse Event Report: ARTHREX, INC. DBL LOADED 4.75MM BC SWVLK; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	DBL LOADED 4.75MM BC SWVLK
Health Effect - Clinical Codes	Pain (1994); Numbness (2415); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On 10/18/2022, it was reported by medwatch via email that an ar-2324bct-2 biocomposite swivelock anchor was implanted in a patient in the year 2020.The patient bent over and a pop in the shoulder was heard followed by a shooting pain down the arm.Patient could not move the arm or feel two fingers for five weeks.An mri was performed two week later, which confirmed that the anchor had shattered in the shoulder.The anchor had broken into four pieces and were removed during a revision surgery on (b)(6) 2021.For over a year, after revision surgery, patient still experiences pain in the shoulder and still cannot feel two fingers.Patient was referred to see a hand doctor for the numbness in the fingers and it was determined that the broken anchor had caused brachial plexus injury, which developed into thoracic outlet syndrome.A thoracic surgeon confirmed the diagnosis.Patient is back to physical therapy and is facing another surgery.
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.

• Brand Name: DBL LOADED 4.75MM BC SWVLK
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 15743259
• Report Number: 1220246-2022-05706
• Device Sequence Number: 5850493
• Product Code: MAI
• UDI-Device Identifier: 00888867251236
• UDI-Public: 00888867251236
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: DBL LOADED 4.75MM BC SWVLK
• Device Catalogue Number: AR-2324BCT-2
• Device Lot Number: 10886414
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 11/07/2022
• Date Device Manufactured: 04/27/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown