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

Catalog Number 6126120000

Device Problem Biocompatibility (2886)

Patient Problem No Patient Involvement (2645)

Event Date 09/01/2016

Event Type  malfunction  

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program, (b)(4).Seventeen (17) devices were received for evaluation.Seventeen (17) events were confirmed during testing.Thirteen (13) devices were found to be affected by a missing o-ring.Three (3) devices were found to have fractured guiderails.One (1) device was found to have a detached hinge.Five (5) device evaluations are in progress.One (1) device is available for evaluation but has not yet been received.This device is not repairable and was not returned to the user facility.There were no remedial actions taken.This device is not labeled for single-use.

Event Description

This report summarizes 23 malfunction events in which the device overheated.Nineteen (19) reported events had no patient involvement; no patient impact.Four (4) reported events had patient involvement; no patient impact.

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program, (b)(4).(b)(4) devices were received for evaluation.(b)(4) events were confirmed during testing.(b)(4)devices were found to be affected by a missing o-ring.(b)(4) devices were found to have fractured guiderails.(b)(4) device was found to have a detached hinge.(b)(4) device evaluations are in progress.(b)(4) device is available for evaluation but has not yet been received.This device is not repairable and was not returned to the user facility.There were no remedial actions taken.This device is not labeled for single-use.

Event Description

This report summarizes 22 malfunction events in which the device overheated.Eighteen reported events had no patient involvement; no patient impact.Four reported events had patient involvement; no patient impact.

Manufacturer Narrative

(b)(4).7 devices were received for evaluation; 7 events were confirmed during testing.4 devices were found to be fractured.3 devices were found to be disassembled.This device is not repairable and was not returned to the user facility.There were no remedial actions taken.This device is not labeled for single-use.

Event Description

This report summarizes 22 malfunction events in which the device overheated.18 reported events had no patient involvement; no patient impact.4 reported events had patient involvement; no patient impact.

• Brand Name: SYSTEM 6 ASEPTIC HOUSING
• 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: 6279642
• MDR Text Key: 66143380
• Report Number: 0001811755-2017-00204
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 22
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/31/2017

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: No Information
• Device Catalogue Number: 6126120000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/01/2016
• Initial Date FDA Received: 01/26/2017
• Supplement Dates Manufacturer Received: Not provided; 09/01/2016
• Supplement Dates FDA Received: 02/07/2017; 07/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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