MAUDE Adverse Event Report: ARTHREX, INC. DBL LOADED 5.5MM BC SWVLK; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	DBL LOADED 5.5MM BC SWVLK
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a shoulder the suture threads contained in the anchor broke cleanly after screwing and removing the blue handle of the swivelock.The anchor remained fixated in the patient.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a new device from another manufacturer.Due to the change of the device a different technique was necessary to finish the surgery successfully.No further information were provided by the customer what kind of technique change has been performed.
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 5.5MM 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: 16459033
• Report Number: 1220246-2023-06363
• Device Sequence Number: 16723400
• Product Code: MAI
• UDI-Device Identifier: 00888867264557
• UDI-Public: 00888867264557
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/01/2023

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: 05/31/2023
• Device Model Number: DBL LOADED 5.5MM BC SWVLK
• Device Catalogue Number: AR-2323BCT-2-1
• Device Lot Number: 13501343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2023
• Initial Report FDA Received Date: 03/01/2023
• Date Device Manufactured: 06/11/2021
• 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