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U.S. Department of Health and Human Services

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

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MEDLINE RENEWAL MEDLINE RENEWAL REPROCESSED ARTHROSCOPIC ABRADER ARTHROSCOPE ACCESSORY Back to Search Results
Model Number 375-951-100
Device Problem Material Fragmentation (1261)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/07/2016
Event Type  malfunction  
Manufacturer Narrative
The device in question was not returned to medline renewal for evaluation. Our investigation included a review of the device history record, and we reconfirmed that all processes were conducted as required, and that the device met inspection requirements prior to packaging and release. The specific cause of the metal shavings could not be determined at this time. Due to the lack of information surrounding the incident, medline renewal does not have enough information to determine the root cause of the failure. The customer confirmed that no adverse patient consequence or medical intervention was required as a result of the incident. However, in an abundance of caution, medline renewal is filing this medwatch report. Device not returned for evaluation.
 
Event Description
Medline renewal received a report indicating that a reprocessed stryker formula barrel bur left metal shavings in the patient during a shoulder arthroscopy procedure. No adverse patient consequence was reported as a result of the incident.
 
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Brand NameMEDLINE RENEWAL REPROCESSED ARTHROSCOPIC ABRADER
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 Key6068233
MDR Text Key58851525
Report Number3032391-2016-00034
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 user facility
Reporter Occupation
Type of Report Initial
Report Date 10/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/31/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/30/2019
Device Model Number375-951-100
Device Lot Number314897
Was Device Available for Evaluation? No
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? Device Not Returned to Manufacturer
Date Device Manufactured08/17/2016
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: 10/31/2016 Patient Sequence Number: 1
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