MAUDE Adverse Event Report: ARTHREX, INC. TITANIUM SWIVELOCK, 4.75X19.1MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	TITANIUM SWIVELOCK, 4.75X19.1MM
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, it was reported by an arthrex employee via email that an ar-2324slm swivelock anchor separated from suture.This was discovered post operation via x-ray.The procedure performed was an reduction and fixation of avulsion fracture of the greater tuberosity of humerus and it took place on (b)(6) 2022.A revision surgery has not yet occurred but it will be schedule for the near future.No further information has been given as of today.Additional information received on 5/9/2022: surgeon became aware of device failure three days after the procedure on (b)(6) 2022.Revision surgery has yet to be schedule.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The most likely cause for the reported failure can be attributed to a patient-specific event.

• Brand Name: TITANIUM SWIVELOCK, 4.75X19.1MM
• 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: 19195817
• Report Number: 1220246-2024-02496
• Device Sequence Number: 18222980
• Product Code: MAI
• UDI-Device Identifier: 00888867026940
• UDI-Public: 00888867026940
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/26/2024

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: 10/31/2025
• Device Model Number: TITANIUM SWIVELOCK, 4.75X19.1MM
• Device Catalogue Number: AR-2324SLM
• Device Lot Number: 12122472
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2022
• Initial Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown