MAUDE Adverse Event Report: ARTHREX, INC. 4.75MM BC KNOTLESS SWIVELOCK W/ TAPE; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	4.75MM BC KNOTLESS SWIVELOCK W/ TAPE
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/02/2021
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2021, it was reported by a sales representative via e-mail that when the surgeon inserted the ar-2324kbcct swivelock anchor into the patient, the screw broke mid shaft.The sales rep explained the patient had soft bone.The fragment was removed and the case was completed by using a new ar-2324kbcct.
Additional Manufacturer Narrative
Complaint confirmed based on the customer provided photo, which displays a biocomposite anchor that broke at the third distal-most screw.However, the cause remains undetermined without physical evaluation of the complaint device.No change in harm was identified.

• Brand Name: 4.75MM BC KNOTLESS SWIVELOCK W/ TAPE
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12507938
• Report Number: 1220246-2021-03691
• Device Sequence Number: 14511015
• Product Code: MAI
• UDI-Device Identifier: 10888867351124
• UDI-Public: 10888867351124
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K193503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2021

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: 12/31/2024
• Device Model Number: 4.75MM BC KNOTLESS SWIVELOCK W/ TAPE
• Device Catalogue Number: AR-2324KBCCT
• Device Lot Number: 12540908
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/03/2021
• Supplement Date Received by Manufacturer: 09/03/2021
• Initial Report FDA Received Date: 09/21/2021
• Supplement Report FDA Received Date: 09/29/2021
• Patient Sequence Number: 1