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

Catalog Number	5400701000
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 20 events were reported for this quarter.Product return status: 3 devices were received.4 devices were not available for evaluation.13 device investigation types have not yet been determined.  event confirmation status: 3 reported events were confirmed; the cause traced to excessive vibration/shaking during shipping and handling.Additional information: 20 devices were labeled for single-use.20 devices were not reprocessed and reused.
Event or Problem Description
This report summarizes 20 malfunction events in which the device had debris in sterile package.20 events had patient involvement; no patient impact.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale 20 previously reported events are included in this follow-up record.  product return status 8 devices were received.12 devices were not available for evaluation.  event confirmation status 8 reported events were confirmed evaluation results devices were found to be affected by excessive vibration/shaking during shipping and handling.
Event or Problem Description
This report summarizes 20 malfunction events in which the device had debris in sterile package.20 events had patient involvement; no patient impact.

• Brand Name: THE MILL DISPOSABLE- MEDIUM
• Common Device Name: 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: 8546026
• Report Number: 0001811755-2019-01374
• Device Sequence Number: 361348
• Product Code: HWE
• UDI-Device Identifier: 34546540604102
• UDI-Public: 34546540604102
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 20
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2019

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
• Operator of Device: No Information
• Device Catalogue Number: 5400701000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/01/2019
• Supplement Date Received by Manufacturer: 01/01/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 07/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1