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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX PROBE

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ARTHREX, INC. ARTHREX PROBE Back to Search Results
Catalog Number AR-10010
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Code Available (3191)
Event Date 04/13/2018
Event Type  malfunction  
Event Description
Surgeon performing knee meniscectomy using probe from arthroscopy instruments. Went to insert probe into patient knee and tip of probe broke off inside of patient. Had to bring in c-arm to locate tip, requiring an additional 30 minutes of or time and anesthesia time.
 
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Brand NameARTHREX
Type of DevicePROBE
Manufacturer (Section D)
ARTHREX, INC.
6875 arthrex commerce drive
ave maria FL 34142
MDR Report Key7498557
MDR Text Key107771465
Report Number7498557
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 04/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberAR-10010
Device Lot Number74598
Other Device ID NumberPROBE, 3.4 MM HOOK
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/24/2018
Device Age2 YR
Event Location Hospital
Date Report to Manufacturer04/24/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/09/2018 Patient Sequence Number: 1
Treatment
NOT APPLICABLE.
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