MAUDE Adverse Event Report: ARTHREX, INC. ZONE NAVIGATOR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	ZONE NAVIGATOR
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/13/2019
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 device was reported to have been discarded.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 during an inside-out meniscal repair procedure, the surgeon used two ar-7900 zone navigators (lot: 10297141 and lot: 10302082).The rep stated both devices malfunctioned in the same procedure.However, it is unknown which issue occurred with each specific lot.During the procedure the surgeon opened one ar-7900 and a mid-posterior cannula.After sliding the cannula on top, the surgeon needed to adjust the cannula.Upon attempting to adjust the cannula, it was extremely difficult to take off the cannula with the grey button depressed all the way down on the handle.A second ar-7900 was opened and the cannula was able to be adjusted much better.However, the needle was bent and not sliding easily into the handpiece so the surgeon switched handpieces with the recommendation to use fresh needles.As the surgeon slid the needle through and tried to advance it, the tolerance was extremely tight and the needle would not advance through.At this point the surgeon then switched to an outside-in technique due to only having one tech scrubbed in.The sales rep reported there was no harm to the patient.The rep confirmed no instrument broke inside the patient.Additional information received on 08/30/2019: the rep reported no unplanned or additional incisions were made.The two defective ar-7900 were discarded after the procedure and will not be returning for evaluation.No pictures were captured during the procedure.The following devices are the part and lot numbers of the cannula and needle(s) used during the procedure: ar-7910r // lot: 907091648.Ar-7905 // lot: 907091649.Ar-7523 // lot: 906491514.

• Brand Name: ZONE NAVIGATOR
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8961163
• Report Number: 1220246-2019-01294
• Device Sequence Number: 2609315
• Product Code: LXH
• UDI-Device Identifier: 00888867300453
• UDI-Public: 00888867300453
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/04/2019

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: 03/31/2024
• Device Model Number: ZONE NAVIGATOR
• Device Catalogue Number: AR-7900
• Device Lot Number: 10302082
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2019
• Initial Report FDA Received Date: 09/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other