MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO EZOUT BLADE PACK, 46MM; INSTRUMENT, SURGICAL, ORTHOPAEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	7812046001K
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device discarded by customer.
Event or Problem Description
It was reported that during a surgical procedure, the blade broke.It was also reported that the broken piece was retrieved from the patient.It was further reported that there were no adverse consequences or delay as a result of this event and the procedure was completed successfully.
Additional Manufacturer Narrative
The reported event, for blade breakage, was not confirmed as the blade was not returned for evaluation.Without the blade, the root cause cannot be determined.
Event or Problem Description
It was reported that during a surgical procedure, the blade broke.It was also reported that the broken piece was retrieved from the patient.It was further reported that there were no adverse consequences or delay as a result of this event and the procedure was completed successfully.

• Brand Name: EZOUT BLADE PACK, 46MM
• 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: 7903140
• Report Number: 0001811755-2018-01673
• Device Sequence Number: 16492559
• Product Code: HWE
• UDI-Device Identifier: 07613327294569
• UDI-Public: 07613327294569
• Combination Product (Y/N): N
• 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): 11/19/2018

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: Health Professional
• Device Expiration Date: 08/01/2021
• Device Catalogue Number: 7812046001K
• Device Lot Number: 16224017
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/28/2018
• Supplement Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 09/24/2018
• Supplement Report FDA Received Date: 11/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1