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 Delivered as Unsterile Product (1421)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 12/25/2018

Event Type  malfunction  

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 5 events were reported for this quarter.Product return status: 3 devices were received.2 devices investigation type have not yet been determined.Evaluation status: 3 reported events were confirmed during testing.3 devices were found to be affected by excessive vibration/shaking during transport.Additional information: 5 devices were labeled for single-use.5 devices were not reprocessed and reused.

Event Description

This report summarizes 5 malfunction events in which the device had debris in sterile package.3 events had patient involvement; no patient impact.2 events had no patient involvement; no patient impact.

Event Description

This report summarizes 23 malfunction events in which the device had debris in sterile package.23 events had patient involvement; no patient impact.

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale: 5 events were originally reported for this failure mode during the reporting quarter.23 events should have been reported; 17 events were excluded.23 events are included in this follow-up record.Product return status 20 devices were received.3 devices were not available for evaluation.Event confirmation status 20 reported events were confirmed; the cause traced to excessive vibration/shaking during shipping and handling.Evaluation results 20 devices were found to be affected by tyvek adhesive particles.Additional information: 23 devices were labeled for single-use.23 devices were not reprocessed and reused.

• 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
• MDR Report Key: 8285195
• MDR Text Key: 134371689
• Report Number: 0001811755-2019-00403
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 04546540604101
• UDI-Public: 4546540604101
• Combination Product (y/n): N
• Number of Events Reported: 23
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 5400701000
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1