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 Consequences Or Impact To Patient (2199)

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).Three events were reported for this quarter.(b)(4) devices were received for evaluation.Two events were confirmed.One device was found to have a compromised weld.One device was found to be affected by a missing component.One device was available for evaluation but has 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 3 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.Two events had no patient involvement; no patient impact.One event 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: 1 previously reported event is included in this follow-up record.Product return status: 1 device was not available to stryker for evaluation.    additional information: 1 device is not labeled for single-use.1 device was not reprocessed and reused.

Event Description

This report summarizes 3 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.2 events had no patient involvement; no patient impact.1 event had patient involvement; no 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
• MDR Report Key: 7220052
• MDR Text Key: 98523748
• Report Number: 0001811755-2018-00291
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Number of Events Reported: 3
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/24/2018

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: 7222120000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/02/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1