MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO THE MILL DISPOSABLE- MEDIUM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number 5400701000

Device Problem Biocompatibility (2886)

Patient Problem No Patient Involvement (2645)

Event Date 09/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Approx 1 device was received for evaluation; 1 event was confirmed during testing.The device was found to be affected by a white dust in the packaging.This device is not repairable and was not returned to the user facility.There were no remedial actions taken.This device is labeled for single-use, but not reprocessed and reused.

Event Description

This report summarizes 1 malfunction event in which the device had dust in the packaging.Approx 1 event had patient involvement; no patient impact.

• Brand Name: THE MILL DISPOSABLE- MEDIUM
• 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-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 6279918
• MDR Text Key: 66054043
• Report Number: 0001811755-2017-00244
• 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: 01/26/2017

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: 5400701000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/01/2016
• Initial Date FDA Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1