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

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.

• Brand Name: MD SERIES LONG STRAIGHT ATTACHMENT
• Type of Device: SMALL 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 Key: 7285046
• MDR Text Key: 100515500
• Report Number: 0001811755-2018-00432
• Device Sequence Number: 1
• Product Code: EIA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K032117
• Number of Events Reported: 1
• 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 Received: 02/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 5100015270
• Device Lot Number: 15150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 1608002015 6.0MM ROUND BUR UNKNOWN SERIAL; 6400-015-000 REMB ELECTRIC MICRO DRILL/ 1510405883
• Patient Outcome(s): Other