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	01/03/2022
Type of Reportable Event	Serious Injury
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
It was reported that during a rotator cuff surgery the suture threads contained in the anchor broke after screwing and removing the green handle from the swivelock.The threads frayed at the junction between the eyelet and the metal guide during impaction and screwing.The device remains in the patient.The surgery was finished successfully with a new device from another manufacturer.According to customer it was necessary to switch the surgical technique, because the anchor could not be used to repair the cap due to the absence of suture.It was not necessary to do a second surgery.Update 25-jan-2022: the anchor stays in patient without the broken sutures, they were removed from patient.The surgeon had to use another anchor from another manufacturer, just next to the first one to finish the procedure.Surgeon had to change the surgical technique a little bit because the arthrex anchor took one place on shoulder.
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
It was reported that during a rotator cuff surgery the suture threads contained in the anchor broke after screwing and removing the green handle from the swivelock.The threads frayed at the junction between the eyelet and the metal guide during impaction and screwing.The device remains in the patient.The surgery was finished successfully with a new device from another manufacturer.According to customer it was necessary to switch the surgical technique, because the anchor could not be used to repair the cap due to the absence of suture.It was not necessary to do a second surgery.Update 25-jan-2022: the anchor stays in patient without the broken sutures, they were removed from patient.The surgeon had to use another anchor from another manufacturer, just next to the first one to finish the procedure.Surgeon had to change the surgical technique a little bit because the arthrex anchor took one place on shoulder.

• 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: 13471015
• Report Number: 1220246-2022-04392
• Device Sequence Number: 11794419
• 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): 02/07/2022

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: 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: 01/18/2022
• Initial Report FDA Received Date: 02/07/2022
• 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