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 03/02/2017

Event Type  malfunction  

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program, exemption number (b)(4).Seven devices were received for evaluation; 4 events were confirmed during testing.Seven devices were found to be affected by a packaging problem.Two devices are available for evaluation but have 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 labeled for single-use.

Event Description

This report summarizes 9 malfunction events in which the device had a white dust observed in the package.There was patient involvement; no patient impact.

Manufacturer Narrative

(b)(4).There were no remedial actions taken.This device is labeled for single-use.Corrected data: 2 devices were expected for evaluation but were not received.

Event Description

This report summarizes 9 malfunction events in which the device had a white dust observed in the package.There was 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-KALAMAZOO; 4100 east milham avenue; highway #3, km 130.2; kalamazoo MI 49001
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 6748091
• MDR Text Key: 81298723
• Report Number: 0001811755-2017-01504
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 9
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/08/2017

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/02/2017
• Initial Date FDA Received: 07/27/2017
• Supplement Dates Manufacturer Received: 03/02/2017
• Supplement Dates FDA Received: 09/08/2017
• 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