MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO BATTERY CHARGER, 120 VOLT"; INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number 4110120000

Device Problem Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Date 05/30/2014

Event Type  malfunction  

Event Description

It was reported that the battery charger is smoking while charging the batteries at the user facility.No associated procedure, no patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.

Manufacturer Narrative

The reported event, charger is not working and is smoking, was not duplicated, however it was confirmed that plastic on the third module had melted.Through visual inspection, the engineer observed the plastic on the third module where the batteries are seated was deformed due to heat.Although overheating and smoking were not observed during testing, the engineer determined that the cause of the overheating was most likely caused by a faulty battery.The third module was replaced, preventative maintenance was performed and the charger was returned to the customer.The ifu also advises users not to place a battery in a module until the module is connected to the charger.Failure to do so can cause the module to become hot with the potential to burn.

Event Description

It was reported that the battery charger is smoking while charging the batteries at the user facility.No associated procedure, no patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.

Manufacturer Narrative

The device has been received, but the evaluation has not yet begun.Additional information may be submitted once the quality investigation is complete.

• Brand Name: BATTERY CHARGER, 120 VOLT"
• 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: 3896591
• MDR Text Key: 4799368
• Report Number: 0001811755-2014-02277
• Device Sequence Number: 1
• Product Code: KIJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4110120000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2004
• 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