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

Catalog Number	6203110000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/01/2018
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: 1 event was reported for this quarter.Product return status: 1 device was received for evaluation.  evaluation status: 1 reported event was not confirmed during testing as the device was received in a condition in which made evaluation not possible.Additional information: 1 device is not labeled for single-use.1 device was not reprocessed and reused.
Event or Problem Description
This report summarizes 1 malfunction event in which the device had a broken cutting accessory still attached.1 event had no patient involvement; no patient impact.

• Brand Name: AO SMALL ATTACHMENT
• 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: 8014240
• Report Number: 0001811755-2018-01913
• Device Sequence Number: 11201320
• Product Code: HWE
• UDI-Device Identifier: 04546540501615
• UDI-Public: 04546540501615
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/29/2018

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: 6203110000
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2018
• Initial Report FDA Received Date: 10/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1