MAUDE Adverse Event Report: ARTHREX, INC. 5.5MM BC KNOTLESS SWIVELOCK; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	5.5MM BC KNOTLESS SWIVELOCK
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2022
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
It was reported on 08/01/2022 by a arthrex employee via email that an ar-2323kbcc suture anchor tip popped off.This was discovered during a case with no patient harm.
Additional Manufacturer Narrative
Complaint confirmed.Upon visual inspection, it was noted that the eyelet was broken.The method used to prepare the bone as well as the bone quality encountered were not provided.The cause of this remains undetermined.

• Brand Name: 5.5MM BC KNOTLESS SWIVELOCK
• 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: 15445972
• Report Number: 1220246-2022-05511
• Device Sequence Number: 12642914
• Product Code: MAI
• UDI-Device Identifier: 10888867351353
• UDI-Public: 10888867351353
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K193503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2022

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: 09/30/2025
• Device Model Number: 5.5MM BC KNOTLESS SWIVELOCK
• Device Catalogue Number: AR-2323KBCC
• Device Lot Number: 14263881
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2022
• Supplement Date Received by Manufacturer: 08/01/2022
• Initial Report FDA Received Date: 09/19/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown