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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS FORMULA BARREL BUR; BURR
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STRYKER INSTRUMENTS FORMULA BARREL BUR; BURR Back to Search Results
Catalog Number 0375-941-0000
Device Problems Overheating of Device (1437); Loss of Power (1475)
Patient Problem Burn(s) (1757)
Event Date 09/26/2014
Event Type  Injury  
Event Description
Patient undergoing shoulder arthroscopy surgery.A stryker tps controller with hand piece was to be used.A 4.0 mm barrel burr was attached for the surgery.It appears the hand piece had overheated and stopped working.The hand piece was resting on the patient's shoulder and caused a slight burn to the patient (estimate 1st to 2nd degree).The controller, hand piece, and barrel burr were taken out of service and sent to biomed for evaluation.Patient received small burn on shoulder.Burned was cared for (site cleaned/dressed).Patient was instructed on what happened and given care instructions to burn.
 
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Brand Name
FORMULA BARREL BUR
Type of Device
BURR
Manufacturer (Section D)
STRYKER INSTRUMENTS
4100 east milham ave.
kalamazoo MI 49001
MDR Report Key4168667
MDR Text Key5089188
Report Number4168667
Device Sequence Number2
Product Code NBH
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 10/10/2014
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Invalid Data
Device Catalogue Number0375-941-0000
Device Lot Number13338CE2
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/10/2014
Event Location Ambulatory Surgical Facility
Date Report to Manufacturer10/14/2014
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/10/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
PIECE: FORMULA, 0375-701-500, REV 11; 400WFOOTSWITCH: TPS FS 5100-008-000 REV 3HAND; ONSOLE: SOFTWARE REV 4.4 B2 RFHARDWARE REV 25; STRYKER TPS CONSOLETAG# 026360SN: 415300573C
Patient Outcome(s) Other; Required Intervention;
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