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 Consequences Or Impact To Patient (2199)

Event Date 12/02/2016

Event Type  malfunction  

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program, exemption number (b)(4).Thirty devices were received for evaluation; 24 events were confirmed during testing.Nine devices were found to be affected hinge fractured, housing intact.Four devices were found to be affected by hinge fractured, the housing in two pieces.Six devices were found to be affected by the housing broke at the level of the weld.Ten devices were found to be affected by a missing o-ring.One device was found to have the guide rails fractured off and a loose o-ring.Six events were not confirmed; the devices were within specifications for the reported event.Two devices are available for evaluation but have 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 32 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 nine reported events had no patient involvement; no patient impact.Three reported events had patient involvement with no patient impact.

Manufacturer Narrative

(b)(4).1 device was received for evaluation.1 event was confirmed.The device was found to have a damaged component.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.Corrected data: 1 device was expected for evaluation; however, the device was not received.

Event Description

This report summarizes 32 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.29 reported events had no patient involvement; no patient impact.3 reported events had patient involvement with 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: 6526393
• MDR Text Key: 74095263
• Report Number: 0001811755-2017-01062
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 32
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/26/2017

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: 12/02/2016
• Initial Date FDA Received: 04/27/2017
• Supplement Dates Manufacturer Received: 12/02/2016
• Supplement Dates FDA Received: 09/26/2017
• 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