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

Catalog Number 7215000000

Device Problem Biocompatibility (2886)

Patient Problem No Patient Involvement (2645)

Event Date 09/01/2016

Event Type  malfunction  

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program, exemption number (b)(4).1 device evaluation is in progress.There were no remedial actions taken.This device is not labeled for single-use.

Event Description

This report summarizes 1 malfunction event in which the device had a condition in which the non-sterile battery had the potential to be exposed to the surgical site.There was patient involvement; no patient impact.

Manufacturer Narrative

(b)(4).There were no remedial actions taken.This device is not labeled for single-use.Correction: 1 device was anticipated for return; however, the device was not received by stryker.

Event Description

This report summarizes 1 malfunction event in which the device had a condition in which the non-sterile battery had the potential to be exposed to the surgical site.There was patient involvement; no patient impact.

Manufacturer Narrative

(b)(4).1 device was received for evaluation.The device was found to be fractured.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 1 malfunction event in which the device had a condition in which the non-sterile battery had the potential to be exposed to the surgical site.There was patient involvement; no patient impact.

• Brand Name: STRYKER SMARTLIFE BATTERY PACK, LARGE
• 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: 6279645
• MDR Text Key: 66135044
• Report Number: 0001811755-2017-00212
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/10/2017

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: 7215000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/01/2016
• Initial Date FDA Received: 01/26/2017
• Supplement Dates Manufacturer Received: 09/01/2016; 09/01/2016
• Supplement Dates FDA Received: 09/01/2017; 11/10/2017
• 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