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

Catalog Number 4115000000

Device Problems Delayed Charge Time (2586); Battery Problem (2885)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/08/2014

Event Type  malfunction  

Event Description

It was reported that the batteries were not charging at user facility and there was a delay of one hour delay to the surgery.The procedure was completed successfully, no medical intervention and no adverse consequences were reported with this event.

Event Description

It was reported that the batteries were not charging at user facility and there was a delay of one hour delay to the surgery.The procedure was completed successfully, no medical intervention and no adverse consequences were reported with this event.

Manufacturer Narrative

The device has been received, failure analysis is in progress; additional information will be submitted once the quality investigation is completed.

Manufacturer Narrative

The reported event, batteries do not charge anymore, was not duplicated.The technician confirmed that the charger indicated ¿replace¿ when the batteries were place on the charger.All four batteries were able to be conditioned to normal capacity; however upon disassembly, all of the batteries had internal vented electrolytes.One battery also had internal corrosion.Devices are placed in parts retention.

• 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: 4146844
• MDR Text Key: 4914538
• Report Number: 0001811755-2014-03510
• Device Sequence Number: 1
• Product Code: KIJ
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K972367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2014
• 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: 13003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2013
• 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