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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX ARTHREX ARTHROSCOPE

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ARTHREX ARTHREX ARTHROSCOPE Back to Search Results
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/29/2016
Event Type  malfunction  
Event Description
During left knee arthroscopy surgeon was using a right angle probe and the tip of the probe broke off while inside the patient. The surgeon used fluoroscopy intra-op and was able to remove the broken tip.
 
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Brand NameARTHREX
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
ARTHREX
MDR Report Key5996399
MDR Text Key56449238
Report NumberMW5065157
Device Sequence Number1
Product Code HRX
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/30/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/30/2016
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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