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	01/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a rotator cuff shoulder arthroscopy two anchors ar-2323bct-2-1 were used.The sutures were damaged after the anchor was placed and three sutures broke.Surgeon had difficulties to repair the patient's rotator cuff.He couldn't squeeze as hard as he wanted to.The anchor with the broken sutures were not retrieved and remains in patient.There was no harm for patient, operator or third party.The surgery was finished successfully with the same device was used anyway.It was not necessary to switch the surgical technique or do a second surgery.Update 19-jan-2022: the broken sutures and the anchor, where the sutures broke, remains in patient.It was not retrieved.And with this anchor the surgery was finished successfully.
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: 13470959
• Report Number: 1220246-2022-04390
• Device Sequence Number: 13900749
• 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: Other Health Care Professional
• 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?: No
• Is this a Product Problem Report?: Yes
• 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
• Patient Sex: Unknown