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 Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 12/02/2017

Event Type  malfunction  

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program, exemption number e2015055.39 events were reported for this quarter.3 devices were not available to stryker for evaluation.3 devices are available for evaluation but have not yet been received.33 devices were received for evaluation.1 device evaluation is in progress.1 event was not confirmed during testing; the device was found to be within specifications for the reported event.31 events were confirmed during testing.20 devices were found to be affected by fractured housing.1 device was found to be affected by a damaged o-ring and a loose component.4 devices were found to have damaged o-rings.4 devices were found to be affected by a loose component.19 of 39 reported devices are in scope of recall pfa # (b)(4) for notification.This device is not repairable and was not returned to the user facility.There were no further remedial actions taken.This device is not labeled for single-use.

Event Description

This report summarizes 39 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.5 events had no patient involvement; no patient impact.34 events had patient involvement; no patient impact.

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program, exemption number e2015055.  supplemental rationale corrected data: 6 previously reported events are included in this follow-up record.Product return status: 3 devices were received for evaluation.3 devices were not available to stryker for evaluation.      evaluation status: 3 reported events were confirmed during testing. 2 devices were found to be affected by a fracture problem.1 device was found to be affected by a mechanical problem.  additional information: 1 of 6 reported devices are in scope of recall pfa # (b)(4) for notification.6 devices were not labeled for single-use.6 devices were not reprocessed and reused.

Event Description

This report summarizes 39 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.5 events had no patient involvement; no patient impact.34 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
• MDR Report Key: 7466634
• MDR Text Key: 106956052
• Report Number: 0001811755-2018-00666
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Number of Events Reported: 39
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 7126120000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/02/2017
• Initial Date FDA Received: 04/26/2018
• Supplement Dates Manufacturer Received: 12/02/2017
• Supplement Dates FDA Received: 10/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1