MAUDE Adverse Event Report: ARTHREX, INC. 45 DEG CURVE RIGHT, FASTPASS LASSO; PLATE, FIXATION, BONE

Model Number	45 DEG CURVE RIGHT, FASTPASS LASSO
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2021
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
It was reported that during a bankart surgery, one lasso got bent and one broke-off inside the patient but it was retrieved from the patient.No harm for patient, operator or third party was reported.The surgery was finished successfully with a different device.It was not necessary to switch the surgical technique or do a second surgery.***update 05-may-2021: a new device from another manufacturer was used to finish the surgery successfully.
Additional Manufacturer Narrative
Complaint confirmed, one curved tip broke off and the other one is bent.Evaluation shows the broken tip was also bent prior to breaking off.No other abnormality observed.The material of the tips was found to meet specifications.A likely cause of the event is prying/leveraging the device during use.

• Brand Name: 45 DEG CURVE RIGHT, FASTPASS LASSO
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11871639
• Report Number: 1220246-2021-03122
• Device Sequence Number: 11829526
• Product Code: LXH
• UDI-Device Identifier: 00888867038936
• UDI-Public: 00888867038936
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2021

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: 10/31/2023
• Device Model Number: 45 DEG CURVE RIGHT, FASTPASS LASSO
• Device Catalogue Number: AR-6068-45R
• Device Lot Number: 832188162
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 05/03/2021
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 06/25/2021
• Patient Sequence Number: 1