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

Model Number	DBL LOADED 4.75MM BC SWVLK
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/31/2021
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.
Event or Problem Description
It was reported that at the end of the shoulder rotator cuff repair surgery the second inside sutures of the devices broke inside the patient.At the end of the surgery, when the second tigertail has to be removed from the eyelet and through the screw, the sutures broke.The surgeon pulled on one side of the suture to remove it totally but only one half came out, the second half stayed inside the screw.Update 22-apr-2021: it was confirmed that the fibertail & tigertail sutures of the devices broke inside the patient, which are not the primary repair.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: DBL LOADED 4.75MM BC SWVLK
• Common Device Name: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11711784
• Report Number: 1220246-2021-02936
• Device Sequence Number: 3846774
• Product Code: MAI
• UDI-Device Identifier: 00888867264571
• UDI-Public: 00888867264571
• 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,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/22/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: DBL LOADED 4.75MM BC SWVLK
• Device Catalogue Number: AR-2324BCT-2-1
• Device Lot Number: 11989511
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 04/22/2021
• Patient Sequence Number: 1