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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. PROBE, HOOK 3.4MM TIP W/5MM MARKINGS; ORTHOPEDIC MANUAL SURG INSTR

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ARTHREX, INC. PROBE, HOOK 3.4MM TIP W/5MM MARKINGS; ORTHOPEDIC MANUAL SURG INSTR Back to Search Results
Model Number PROBE, HOOK 3.4MM TIP W/5MM MARKINGS
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/12/2021
Event Type  malfunction  
Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on (b)(6) 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Event description: it was reported that the device is bent.The reported event was confirmed as the evaluation revealed that the shaft is bent.This is typically caused by applying excessive leveraging forces.
 
Event Description
It was reported that the device is bent.There was no harm or adverse event for patient, operator or third party reported.No further information received.
 
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Brand Name
PROBE, HOOK 3.4MM TIP W/5MM MARKINGS
Type of Device
ORTHOPEDIC MANUAL SURG INSTR
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 Key19211978
MDR Text Key341363979
Report Number1220246-2024-02594
Device Sequence Number1
Product Code LXH
UDI-Device Identifier00888867002364
UDI-Public00888867002364
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 04/30/2024
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 NumberPROBE, HOOK 3.4MM TIP W/5MM MARKINGS
Device Catalogue NumberAR-10010
Device Lot Number04844
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/26/2021
Initial Date Manufacturer Received 10/12/2021
Initial Date FDA Received04/30/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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