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

Catalog Number 7222120000

Device Problem Biocompatibility (2886)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/02/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Eighteen events were reported for this quarter.Fifteen devices were received for evaluation; fifteen events were confirmed during testing.Nine devices were found to be affected by fractured housing.Five devices were found to have missing components.One device was found to have a swollen component.Three 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 18 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.Thirteen events had no patient involvement; no patient impact.Three events had patient involvement; no patient impact.Two events had no known patient involvement; no known patient impact.

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program, exemption number (b)(4).One device was received for evaluation; 1 event was confirmed during testing.One device was found to be affected by fractured housing rails.This device is not repairable and was not returned to the user facility.Correction: 2 devices were expected for evaluation but were not received.There were no remedial actions taken.This device is not labeled for single-use.

Event Description

This report summarizes 18 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.Thirteen events had no patient involvement; no patient impact.Three events had patient involvement; no patient impact.Two events had no known patient involvement; no known patient impact.

• Brand Name: SMARTLIFE SMALL ASPTC 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: 6980719
• MDR Text Key: 91262672
• Report Number: 0001811755-2017-02069
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 18
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/26/2018

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: 7222120000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/02/2017
• 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