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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. CONIC OBTR,FOR 4MM SCOPE SHTH; ARTHROSCOPE AND ACCESSORIES

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ARTHREX, INC. CONIC OBTR,FOR 4MM SCOPE SHTH; ARTHROSCOPE AND ACCESSORIES Back to Search Results
Model Number CONIC OBTR,FOR 4MM SCOPE SHTH
Device Problem Naturally Worn (2988)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/09/2021
Event Type  malfunction  
Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint is confirmed.Device was received: ar-3375-4011, batch 1456758, unpackaged.Observation revealed discoloration consistent with rust and pitting along the shaft of the device.The cause of this event is most likely wear due to age.
 
Event Description
It was reported that there is pitting corrosion with this device.There was no harm for patient, operator or third-party reported.No further information was received.
 
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Brand Name
CONIC OBTR,FOR 4MM SCOPE SHTH
Type of Device
ARTHROSCOPE AND ACCESSORIES
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer (Section G)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer Contact
jared engle
8009337001
MDR Report Key19191212
MDR Text Key341788777
Report Number1220246-2024-02445
Device Sequence Number1
Product Code NBH
UDI-Device Identifier00888867101616
UDI-Public00888867101616
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/26/2024
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
Device Operator Health Professional
Device Model NumberCONIC OBTR,FOR 4MM SCOPE SHTH
Device Catalogue NumberAR-3375-4011
Device Lot Number1456758
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/23/2021
Initial Date Manufacturer Received 08/09/2021
Initial Date FDA Received04/26/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/26/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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