MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO EZOUT BLADE PACK, 44MM; INSTRUMENT, SURGICAL, ORTHOPAEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	7812044001K
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/05/2017
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 a replacement surgery procedure, after removing the socket, the ezout saw blade broke, the broken blade was removed using forceps.It was also reported that there was no delay and no adverse consequences as a result of this event.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 blade.A device history review(dhr) was performed and all manufacturing specifications were met during the time of manufacture of this product.The returned blade was evaluated by the product subject matter expert(sme) where from the analysis carried out, showed that the blade was used in an aggressive manner up to the time of fracture.The instructions for use (ifu) for the ezout acetabular cup removal system (7202-001-700) include warnings under the section ¿to operate the handpiece¿ that outline the user is not apply excessive pressure in the form of bending, prying or excessive twisting, which may result in the bend or fracture of the blade or attachment.
Event or Problem Description
It was reported that during a replacement surgery procedure, after removing the socket, the ezout saw blade broke, the broken blade was removed using forceps.It was also reported that there was no delay and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.

• Brand Name: EZOUT BLADE PACK, 44MM
• 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: 6536789
• Report Number: 0001811755-2017-01216
• Device Sequence Number: 11106143
• Product Code: HWE
• UDI-Device Identifier: 07613327294453
• UDI-Public: (01)07613327294453(17)210201(10)16054017
• 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: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2017

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: 02/01/2021
• Device Model Number: 7812044001K
• Device Catalogue Number: 7812044001K
• Device Lot Number: 16054017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2017
• Initial Date Received by Manufacturer: 04/05/2017
• Supplement Date Received by Manufacturer: 08/23/2017
• Initial Report FDA Received Date: 05/02/2017
• Supplement Report FDA Received Date: 08/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR