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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO MD SERIES LONG STRAIGHT ATTACHMENT SMALL BONE POWERED SURGICAL SYSTEMS

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STRYKER INSTRUMENTS-KALAMAZOO MD SERIES LONG STRAIGHT ATTACHMENT SMALL BONE POWERED SURGICAL SYSTEMS Back to Search Results
Catalog Number 5100015270
Device Problem Overheating of Device (1437)
Patient Problem Burn(s) (1757)
Event Date 01/29/2018
Event Type  Injury  
Event Description
The user facility reported that the attachment overheated during an orbital face decompression procedure while milling the orbital face. The patient received a 2nd degree burn on the eyelid. There was a 20 minute delay. The burn was cooled with ice and a serum compress and gelonet and vaseline were applied to the skin.
 
Event Description
The user facility reported that the attachment overheated during an orbital face decompression procedure while milling the orbital face. The patient received a 2nd degree burn on the eyelid. There was a 20 minute delay. The burn was cooled with ice and a serum compress and gelonet and vaseline were applied to the skin.
 
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Brand NameMD SERIES LONG STRAIGHT ATTACHMENT
Type of DeviceSMALL BONE POWERED SURGICAL SYSTEMS
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer Contact
zachary baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key7285046
MDR Text Key100515500
Report Number0001811755-2018-00432
Device Sequence Number1
Product Code EIA
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K032117
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Nursing Assistant
Type of Report Initial,Followup
Report Date 05/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number5100015270
Device Lot Number15150
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/22/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/30/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/30/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 02/21/2018 Patient Sequence Number: 1
Treatment
1608002015 6.0MM ROUND BUR UNKNOWN SERIAL; 6400-015-000 REMB ELECTRIC MICRO DRILL/ 1510405883
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