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 Consequences Or Impact To Patient (2199)
Date of Event	12/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.
Event or Problem Description
It was reported that during hip surgery, the blade broke.It was further reported that the event caused a minor delay of unknown duration.It was also reported that all blade fragments were retrieved from the patient successfully and no adverse consequences occurred.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
The reported event, for blade breakage, was confirmed on receipt of the returned blade.The blade was evaluated by product engineering who concluded that the two fractured portions of the returned part showed signs of rounding of the teeth confirm the event description that the blade came into contact with a metal fin during use.This sudden contact would cause the blade to fracture.
Event or Problem Description
It was reported that during hip surgery, the blade broke.It was further reported that the event caused a minor delay of unknown duration.It was also reported that all blade fragments were retrieved from the patient successfully and no adverse consequences occurred.It was further reported that the procedure was completed successfully.

• 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: 7167179
• Report Number: 0001811755-2018-00011
• Device Sequence Number: 11126725
• Product Code: HWE
• UDI-Device Identifier: 07613327294538
• UDI-Public: 7613327294538
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/07/2018

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 Catalogue Number: 7812052001K
• Device Lot Number: 16085017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Initial Date Received by Manufacturer: 12/08/2017
• Supplement Date Received by Manufacturer: 02/07/2018
• Initial Report FDA Received Date: 01/05/2018
• Supplement Report FDA Received Date: 02/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1