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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. ZONE NAVIGATOR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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ARTHREX, INC. ZONE NAVIGATOR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Model Number ZONE NAVIGATOR
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.
 
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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 Key11842384
Report Number1220246-2021-03107
Device Sequence Number19769992
Product Code LXH
UDI-Device Identifier00888867300453
UDI-Public00888867300453
Combination Product (Y/N)N
Initial Reporter CountryAU
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
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 Date03/31/2025
Device Model NumberZONE NAVIGATOR
Device Catalogue NumberAR-7900
Device Lot Number10822462
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 Date05/18/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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