MAUDE Adverse Event Report: ARTHREX, INC. 45 DEG CURVE LEFT, QUICKPASS LASSO; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	45 DEG CURVE LEFT, QUICKPASS LASSO
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/30/2020
Type of Reportable Event	Serious Injury
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 during an arthroscopic shoulder stabilization the tip of the instrument caught against the glenoid, and broke off.The part remained inside the patient and the surgery was changed to an open stabilization.The surgery was finished successfully with a new device with the same part number.Update 13-aug-2020: further information was provided that the broken part was retrieved, however the surgeon spent over an hour trying to get it arthroscopicly, as it fell down to the inferior capsular.The surgeon therefore changed the procedure to an open one to retrieve the device out of the patient.
Additional Manufacturer Narrative
Complaint confirmed, the curved tip was found to have broken off near the weld.A likely cause of the event is prying/leveraging the device during use.

• Brand Name: 45 DEG CURVE LEFT, QUICKPASS LASSO
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10443208
• Report Number: 1220246-2020-02088
• Device Sequence Number: 2452453
• Product Code: LXH
• UDI-Device Identifier: 00888867038929
• UDI-Public: 00888867038929
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2020

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 Model Number: 45 DEG CURVE LEFT, QUICKPASS LASSO
• Device Catalogue Number: AR-6068-45L
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/10/2020
• Supplement Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 08/24/2020
• Supplement Report FDA Received Date: 10/06/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other