MAUDE Adverse Event Report: ARTHREX, INC. 25 DEG TIGHT CURVE LEFT, QUICKPASS LASSO; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	25 DEG TIGHT CURVE LEFT, QUICKPASS LASSO
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/02/2021
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.
Event or Problem Description
It was reported that a quantity two ar-6068-25tl (lot: 000399887) broke right at the end of the shaft.
Additional Manufacturer Narrative
It was reported that the tip of the devices broke.Visual evaluation identified that both tips had broken off the distal end of the device.However, without the return of the product, further investigation cannot be performed.Additionally, patient bone quality and surgical procedure technique were not reported.The root cause of the reported failure mode is undetermined.However, the most likely probable cause is applying excessive mechanical forces while prying / leveraging the devices.

• Brand Name: 25 DEG TIGHT 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: 11692665
• Report Number: 1220246-2021-02925
• Device Sequence Number: 19875874
• Product Code: LXH
• UDI-Device Identifier: 00888867038899
• UDI-Public: 00888867038899
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 05/03/2021

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 Model Number: 25 DEG TIGHT CURVE LEFT, QUICKPASS LASSO
• Device Catalogue Number: AR-6068-25TL
• Device Lot Number: 000399887
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/02/2021
• Supplement Date Received by Manufacturer: 04/02/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 05/03/2021
• Patient Sequence Number: 1