MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO ELITE HELIOCOIDAL RASP; INSTRUMENT, SURGICAL, ORTHOPAEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	5820080021
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number e2015055.2 events were reported for this quarter.2 devices were not available to stryker for evaluation.No further evaluation was possible.2 devices were labelled for single-use.2 devices were not reprocessed and reused.Device not returned.
Event or Problem Description
This report summarizes 2 malfunction events in which the device broke during extraction of a competitor hip implant, while removing hard bone cement.There was patient involvement.There was no patient impact.

• Brand Name: ELITE HELIOCOIDAL RASP
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPAEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8001665
• Report Number: 0001811755-2018-01783
• Device Sequence Number: 1030042
• Product Code: HWE
• UDI-Device Identifier: 07613153022374
• UDI-Public: 07613153022374
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 5820080021
• Device Lot Number: E2015055
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2018
• Initial Report FDA Received Date: 10/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1