MAUDE Adverse Event Report: ARTHREX, INC. BONEY BANKART LASSO, LEFT; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	BONEY BANKART LASSO, LEFT
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/27/2022
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
On 7/27/2022 it was reported by a sales representative via sems that an sp-5068-40bbl boney bankart lasso broke during a case.The surgeon was performing a bony bankart labral repair of the left shoulder.During the passage of suture around the fragment the tip of the hook broke off inside the joint.The in tact portion of the passer was removed from the joint and the broken tip was retrieved as well.The case was completed successfully using a reelpass suture passer.
Additional Manufacturer Narrative
Complaint confirmed.The visual evaluation revealed that the lasso's hooked, distal tip has broken at the laser weld.The tip was not returned along with the shaft of the sp-5068-40bbl.This event is most likely caused by prying/levering the device against hard bone or other instrumentation during use.

• Brand Name: BONEY BANKART LASSO, LEFT
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• 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: 15224030
• Report Number: 1220246-2022-05372
• Device Sequence Number: 14853653
• Product Code: MDM
• UDI-Device Identifier: 00888867221215
• UDI-Public: 00888867221215
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 11/17/2022

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 Model Number: BONEY BANKART LASSO, LEFT
• Device Catalogue Number: SP-5068-40BBL
• Device Lot Number: 0071805
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2022
• Supplement Date Received by Manufacturer: 07/27/2022
• Initial Report FDA Received Date: 08/15/2022
• Supplement Report FDA Received Date: 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown