MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SYSTEM 6 ASEPTIC HOUSING ASSY; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number 6126120000

Device Problems Mechanical Problem (1384); Device Disinfection Or Sterilization Issue (2909)

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

Event Date 08/13/2015

Event Type  malfunction  

Manufacturer Narrative

Failure analysis is in progress; additional information will be submitted once the quality investigation is completed.

Event Description

It was reported that during a surgical procedure at the user facility, the lid of the device opened, potentially exposing the surgical site to a non-sterile battery.The procedure was completed successfully.No delay, no medical intervention, and no adverse consequences were reported with this event.

Manufacturer Narrative

As this is not a repairable device, it was not returned to the customer.

Event Description

It was reported that during a surgical procedure at the user facility the lid of the device opened, potentially exposing the surgical site to a non-sterile battery.The procedure was completed successfully.No delay, no medical intervention, and no adverse consequences were reported with this event.

• Brand Name: SYSTEM 6 ASEPTIC HOUSING ASSY
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-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: 5067244
• MDR Text Key: 25360603
• Report Number: 0001811755-2015-03308
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Followup
• Report Date: 08/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6126120000
• Device Lot Number: 15146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2015
• 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