MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 1/4 INCH REAMER WITH JACOBS CHUCK; INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number 4103231000

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 01/09/2015

Event Type  malfunction  

Event Description

It was reported that during equipment cleaning by the customer at the user facility, the attachment leaked oil.As this event occurred during cleaning at the user facility, there was no patient involvement, no delay, no medical intervention, and no adverse consequences.

Event Description

It was reported that during equipment cleaning by the customer at the user facility that the attachment leaked oil.As this event occurred during cleaning at the user facility, there was no patient involvement, no delay, no medical intervention, and no adverse consequences.

Manufacturer Narrative

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

Manufacturer Narrative

The reported event, attachment is leaking oil, was confirmed.Device was placed in parts retention.

• Brand Name: 1/4 INCH REAMER WITH JACOBS CHUCK
• 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: 4501276
• MDR Text Key: 5337480
• Report Number: 0001811755-2015-00424
• 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: 01/13/2015

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: 4103231000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/02/2015
• Initial Date FDA Received: 02/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2014
• 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