MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO EZOUT BLADE PACK, 52MM; INSTRUMENT, SURGICAL, ORTHOPAEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	7812052001K
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting product return.
Event or Problem Description
It was reported that during a surgical procedure, the blade broke in half.It was further reported that the broken fragment was retrieved and the blade was replaced.It was also reported that there were no medical intervention, no delays and the procedure was completed successfully.No adverse consequences were reported as a result of this event.
Additional Manufacturer Narrative
The device was not returned for investigation.The quality investigation is complete.Device discarded.
Event or Problem Description
It was reported that during a surgical procedure, the blade broke in half.It was further reported that the broken fragment was retrieved and the blade was replaced.It was also reported that there were no medical intervention, no delays and the procedure was completed successfully.No adverse consequences were reported as a result of this event.

• Brand Name: EZOUT BLADE PACK, 52MM
• 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: 8383128
• Report Number: 0001811755-2019-00696
• Device Sequence Number: 1976015
• Product Code: HWE
• UDI-Device Identifier: 07613327294538
• UDI-Public: 07613327294538
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2019

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: Health Professional
• Device Catalogue Number: 7812052001K
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/04/2019
• Supplement Date Received by Manufacturer: 04/19/2019
• Initial Report FDA Received Date: 03/01/2019
• Supplement Report FDA Received Date: 04/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1