MAUDE Adverse Event Report: ARTHREX, INC. CRESCENT, QUICKPASS LASSO; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	CRESCENT, QUICKPASS LASSO
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/27/2020
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.
Event or Problem Description
It was reported that the tip of the device snapped off and became loose in the patient.The loose part was retrieved from the patient and the surgery was successfully completed using a rhino passer.Surgery performed was a shoulder stabilization surgery.Update 03-sep-2020: information received today that surgeon had to switch to an open procedure to remove the broken tip.
Additional Manufacturer Narrative
Complaint confirmed, the curved tip was found to have broken off near the weld.This event is most likely caused by the application of prying/leveraging forces to the device during use.

• Brand Name: CRESCENT, QUICKPASS LASSO
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10546242
• Report Number: 1220246-2020-02170
• Device Sequence Number: 3033160
• Product Code: LXH
• UDI-Device Identifier: 00888867038981
• UDI-Public: 00888867038981
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: CRESCENT, QUICKPASS LASSO
• Device Catalogue Number: AR-6068C
• Device Lot Number: 906491498
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/03/2020
• Supplement Date Received by Manufacturer: 09/03/2020
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 04/01/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other