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 06/02/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Twenty-four events were reported for this quarter.Twenty-three devices were received for evaluation; twenty-two events were confirmed during testing.Eight devices were found to be fractured.Thirteen devices were found to have missing components.One device was found to have a swollen component.One device evaluation is in progress.One device was 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 24 malfunction events in which the device had a condition in which the non-sterile battery had the potential to be exposed to the surgical site.Twenty-three events had no patient involvement; no patient impact.One event had patient involvement; no patient impact.

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program, exemption number e2015055.Supplemental rationale: 2 previously reported events are included in this follow-up record.Product return status: 2 devices were not available to stryker for evaluation.    additional information: 2 devices were not labeled for single-use.2 devices were not reprocessed and reused.Device not received for evaluation.

Event Description

This report summarizes 24 malfunction events in which the device had a condition in which the non-sterile battery had the potential to be exposed to the surgical site.23 events had no patient involvement; no patient impact.1 event 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: zach baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 6980751
• MDR Text Key: 91210777
• Report Number: 0001811755-2017-02100
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 24
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• 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
• Date Manufacturer Received: 06/02/2017
• Was Device Evaluated by Manufacturer?: No
• 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