MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO BATTERY; INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number 4115000000

Device Problems Fluid/Blood Leak (1250); Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Date 05/06/2013

Event Type  malfunction  

Manufacturer Narrative

This report was reported in error under the alternative report number (b)(4) on (b)(4) 2013.The device was scrapped by stryker.

Event Description

It was reported that the system 4 battery allegedly overheated and emitted steam while charging at the user facility.The device was then returned to stryker instruments for evaluation where it was found to have externally and internally vented electrolytes.There was no patient involvement and no adverse consequences associated with the device.

• Brand Name: BATTERY
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• 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: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 5398272
• MDR Text Key: 37094212
• Report Number: 0001811755-2016-00111
• Device Sequence Number: 1
• Product Code: KIJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/06/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4115000000
• Device Lot Number: 11027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2013
• Initial Date Manufacturer Received: 05/06/2013
• Initial Date FDA Received: 01/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2011
• 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