MAUDE Adverse Event Report: ARTHREX, INC. MID/POST CANNULA, LEFT, ZONENAVIGATOR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	MID/POST CANNULA, LEFT, ZONENAVIGATOR
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/22/2021
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that the patient got an infection after he was treated with the devices ar-7900 (lot: 10822462), ar-7910l (lot: 928497924) and ar-7523 (lot: 934399472).This was noticed after the surgery.No further information received.

• Brand Name: MID/POST CANNULA, LEFT, ZONENAVIGATOR
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11842360
• Report Number: 1220246-2021-03106
• Device Sequence Number: 14389603
• Product Code: LXH
• UDI-Device Identifier: 00888867300477
• UDI-Public: 00888867300477
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/18/2021

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: 09/30/2024
• Device Model Number: MID/POST CANNULA, LEFT, ZONENAVIGATOR
• Device Catalogue Number: AR-7910L
• Device Lot Number: 928497924
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 05/18/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other