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

Catalog Number 4115000000

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 02/13/2014

Event Type  malfunction  

Event Description

It was reported that the battery was discovered to be leaking during inspection at the user facility.There was no patient involvement, and there were no user injuries or adverse consequences.

Manufacturer Narrative

The reported event, battery is leaking, was confirmed by the technician.Upon disassembly, the external contact was found to be corroded with signs of water ingress, along with internal corrosion.Based on the device inspection and review of risk documentation the presence of corrosion internally or externally can be caused or contributed to improper sterilization.The device was scrapped by the manufacturer.

Event Description

It was reported that the battery was discovered to be leaking during inspection at the user facility.There was no patient involvement, and there were no user injuries or adverse consequences.

Manufacturer Narrative

Follow up report will be filed after the device is received and the quality investigation has been completed.Not yet received by manufacturer.

• 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: 3663427
• MDR Text Key: 4685502
• Report Number: 0001811755-2014-00768
• Device Sequence Number: 1
• Product Code: KIJ
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K972367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2014
• 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: 13037
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2013
• 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