MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO EZOUT BLADE PACK, 54MM; INSTRUMENT, SURGICAL, ORTHOPAEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	7812054001K
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting device return to manufacturer.
Event or Problem Description
It was reported that during a surgical procedure, it was noted that the blade broke and was retrieved by the surgeon.It was also reported there were no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.
Event or Problem Description
It was reported that during a surgical procedure, it was noted that the blade broke and was retrieved by the surgeon.It was also reported there were no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.Update; it was further reported that a delay of 3 minutes occurred due to this event.
Additional Manufacturer Narrative
He reported product involved with this event was returned for evaluation and the reported failure of blade breakage was confirmed.The device was sent to the product engineering group who concluded that the wear to the teeth and the outer edge of the blade would suggest that the blade did come into contact with metal while cutting.The fracture occurred in the area where the damage to the outer edge of the blade was sustained.The sudden impact of the blade coming into contact with metal could have caused the blade to fracture.Indications for use within the ifu also state; "the ezout acetabular cup removal system is intended to cut bone and hard tissue around the bone-to-cup interface." the quality investigation is complete.

• Brand Name: EZOUT BLADE PACK, 54MM
• 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: 8588221
• Report Number: 0001811755-2019-01597
• Device Sequence Number: 19216545
• Product Code: HWE
• UDI-Device Identifier: 07613327294507
• UDI-Public: 07613327294507
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 06/27/2019

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: 7812054001K
• Device Lot Number: EZOUT BLADE. COULD BE 1 OF 3
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/09/2019
• Supplement Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 05/07/2019
• Supplement Report FDA Received Date: 06/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1