MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SYSTEM 6 RECIP; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number 6206000000

Device Problem Unintended Power Up (1162)

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

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).Two devices were received for evaluation; 2 events were confirmed during testing.One device was found to have non-stryker modifications.One device was found to have a seized internal component.Two devices are available for evaluation but have not yet been received.There were no remedial actions taken.This device is not labeled for single-use.

Event Description

This report summarizes 4 malfunction events in which the device either ran without user activation or experienced a condition in which it was possible to run without user activation.There was no patient involvement; no patient impact.

Manufacturer Narrative

(b)(4).2 devices were received for evaluation.1 event was duplicated.The reported event was not confirmed for 1 device; the device was found to be within specifications for the reported event.2 devices were found to have a malfunctioning electrical component.There were no remedial actions taken.This device is not labeled for single-use.

Event Description

This report summarizes 4 malfunction events in which the device either ran without user activation or experienced a condition in which it was possible to run without user activation.There was no patient involvement; no patient impact.

• Brand Name: SYSTEM 6 RECIP
• 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: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 6280373
• MDR Text Key: 66134212
• Report Number: 0001811755-2017-00356
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 4
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/31/2017

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: 6206000000
• 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
• Supplement Dates FDA Received: 07/31/2017
• 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