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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE RENEWAL ARTHEX AR-4068-25TL @SUTLASSO SD, 25 DEGREE TIG

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MEDLINE RENEWAL ARTHEX AR-4068-25TL @SUTLASSO SD, 25 DEGREE TIG Back to Search Results
Catalog Number AR406825TRH
Device Problem Material Fragmentation (1261)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/06/2020
Event Type  malfunction  
Manufacturer Narrative
Detailed description of the event: it was reported that shavings of the arthex suturelasso sd had to be irrigated out of the patient. According to the customer, while the surgeon was repairing a rotator cuff, the reprocessed suture lasso broke. Reportedly, the reprocessed shaver left metal flakes in the patient's shoulder, during the arthroscopy procedure. Due to the need for medical intervention and in an abundance of caution, this is an mdr reportable event. No additional information is available at this time. If additional information becomes available, this report will be re-opened and re-evaluated.
 
Event Description
It was reported that shavings of the arthex suturelasso sd had to be irrigated out of the patient.
 
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Brand NameARTHEX
Type of DeviceAR-4068-25TL @SUTLASSO SD, 25 DEGREE TIG
Manufacturer (Section D)
MEDLINE RENEWAL
1500 ne hemlock ave
redmond, or
Manufacturer Contact
kathy woods
three lakes drive
northfield, il 
9317708
MDR Report Key10135879
MDR Text Key202222374
Report Number3032391-2020-00004
Device Sequence Number1
Product Code HWQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial
Report Date 06/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberAR406825TRH
Device Lot Number413844
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/13/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/09/2020 Patient Sequence Number: 1
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