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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE RENEWAL MEDLINE RENEWAL REPROCESSED ARTHROSCOPIC SHAVER ARTHROSCOPE ACCESSORY

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MEDLINE RENEWAL MEDLINE RENEWAL REPROCESSED ARTHROSCOPIC SHAVER ARTHROSCOPE ACCESSORY Back to Search Results
Model Number 375-544-000
Device Problem Material Fragmentation (1261)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/21/2016
Event Type  malfunction  
Manufacturer Narrative
The device in question (as well as the broken tip) was returned to medline renewal for evaluation. Upon receipt, medline renewal confirmed the device had been reprocessed. Our evaluation confirmed that the tip of the smaller, innermost shaft was missing and that the tip of the device was retrieved during the procedure. Our investigation also included a review of the device history record. We reconfirmed that all processes were conducted as required, and that the device met inspection and lubrication requirements prior to packaging and release. Unfortunately, the specific cause of the device failure is unknown at this time. Per the device instructions for use (ifu) if a rotating shaver or bur contacts another surgical instrument during activation, device integrity and effectiveness may be compromised. In the event that contact occurs, the user should inspect the tip before proceeding. Although the patient was not harmed, medical intervention was required to retrieve the device tip and obtain a new device, therefore medline renewal is filing this medwatch report in abundance of caution.
 
Event Description
Medline renewal received a report indicating that the tip of a reprocessed stryker formula aggressive plus cutter, model 375-544-000, broke off in the patient's shoulder during use. The report did not indicate that the device failure resulted in patient harm. Another device was readily available to complete the procedure; therefore no patient harm or additional medical intervention was reported as a result of the incident.
 
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Brand NameMEDLINE RENEWAL REPROCESSED ARTHROSCOPIC SHAVER
Type of DeviceARTHROSCOPE ACCESSORY
Manufacturer (Section D)
MEDLINE RENEWAL
2747 sw 6th st.
redmond OR 97756
Manufacturer (Section G)
MEDLINE RENEWAL
2747 sw 6th st.
redmond OR 97756
Manufacturer Contact
brandi panteleon
2747 sw 6th st.
redmond, OR 97756
5415164180
MDR Report Key6071501
MDR Text Key59017066
Report Number3032391-2016-00038
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K012667
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 11/01/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/30/2019
Device Model Number375-544-000
Device Lot Number280166
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/24/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/04/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/28/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 11/01/2016 Patient Sequence Number: 1
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