MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SMARTLIFE LARGE ASPETIC HOUSING; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number 7126120000

Device Problem Biocompatibility (2886)

Patient Problem No Patient Involvement (2645)

Event Date 03/02/2017

Event Type  malfunction  

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program, exemption number (b)(4).Thirty four devices were received for evaluation; 34 events were confirmed during testing.Twenty eight devices were found to be affected by a compromised weld.Three devices were found to be affected by a swollen o-ring.One device had a damaged o-ring.Two devices had a missing o-ring.Ten devices are available for evaluation but have not yet been received.Two devices were not available to stryker for evaluation.Eighteen of 46 reported devices are in scope of recall pfa # ra2016-193 for replace.Sixteen of 46 reported devices are in scope of recall pfa # ra2016-193 for notification.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 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 one reported events had no patient involvement; no patient impact.Twenty five reported events had patient involvement; no patient impact.

Manufacturer Narrative

Fifteen of 46 reported devices are in scope of recall pfa # ra2016-193 for notification.

Event Description

This report summarizes 45 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 reported events had no patient involvement; no patient impact.Twenty five reported events had patient involvement; no patient impact.

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program, exemption number (b)(4).2 devices were received.1 device was not received; however, pictures of the device were evaluated.3 events were confirmed.2 devices were found to have a fractured weld.1 device was found to have a torn o-ring.This device is not repairable and was not returned to the user facility.Correction: 6 devices were expected for returned; however, they were not received.18 of 45 reported devices are in scope of recall pfa # ra2016-193 for replace.16 of 45 reported devices are in scope of recall pfa # ra2016-193 for notification.

Event Description

This report summarizes 45 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.20 reported events had no patient involvement; no patient impact.25 reported events had patient involvement; no patient impact.

• Brand Name: SMARTLIFE LARGE ASPETIC 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: zachary baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 6748290
• MDR Text Key: 81308869
• Report Number: 0001811755-2017-01547
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 45
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2018

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: 7126120000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/02/2017
• Initial Date FDA Received: 07/27/2017
• Supplement Dates Manufacturer Received: 03/02/2017; 03/02/2017
• Supplement Dates FDA Received: 10/13/2017; 03/01/2018
• 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
• Removal/Correction Number: RA2016-193
• Patient Sequence Number: 1