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 09/02/2017

Event Type  malfunction  

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program, exemption number (b)(4).Forty five events were reported for this quarter.Thirty six devices were received for evaluation; 35 events were confirmed during testing.Twenty nine devices were found to be affected by fractured housing.One device was found to be missing a component.Five devices were found to have damaged components.The reported event was not confirmed for 1 device; the device was found to be within specifications for the reported event.Seven devices are available for evaluation but have not yet been received.Two devices were not available to stryker for evaluation.Three of 45 reported devices are in scope of recall pfa # (b)(4) for replace.Twenty five of 45 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 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.Eleven events had no patient involvement; no patient impact.Thirty four events had patient involvement; no patient impact.

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program, exemption number e2015055.7 devices were expected for evaluation; however, the devices were not received.There were no remedial actions taken.This device is not labeled for single-use.

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.11 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
• 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: 7220068
• MDR Text Key: 98527426
• Report Number: 0001811755-2018-00270
• 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
• Type of Report: Initial,Followup
• Report Date: 02/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2018
• 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
• Date Manufacturer Received: 09/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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