MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SINGLE TRIGGER ROTARY; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number 6203000000

Device Problem Unintended Power Up (1162)

Patient Problem No Patient Involvement (2645)

Event Date 03/02/2016

Event Type  malfunction  

Manufacturer Narrative

This mdr report is part of the 227 pilot program, exemption number (b)(4).The device was not available to stryker for evaluation.There were no remedial actions taken.This device is not labeled for single-use.Device not returned to manufacturer for investigation.

Event Description

This report summarizes 1 malfunction event in which the device ran without user activation.There was no patient involvement; no patient impact.

• Brand Name: SINGLE TRIGGER ROTARY
• 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: 5830831
• MDR Text Key: 51445775
• Report Number: 0001811755-2016-01455
• 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
• Report Date: 03/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 6203000000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/02/2016
• 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