MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP EZOUT BLADE PACK, 60MM; INSTRUMENT, SURGICAL, ORTHOPAEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	7812060001K
Medical Device Problem Code	Vibration (1674)
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	12/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting return of device to manufacturer.
Event or Problem Description
It was reported that during the patient's fourth extended trochanteric osteotomy (eto) surgical procedure, the surgeon experienced vibration while using the ezout blade.The procedure was completed successfully.Following the procedure, the patient experienced sciatic nerve palsy.The surgeon indicates that the patient is recovering.
Additional Manufacturer Narrative
H6: the quality investigation is complete.H3 other text : device not available for return.
Event or Problem Description
It was reported that during the patient's fourth extended trochanteric osteotomy (eto) surgical procedure, the surgeon experienced vibration while using the ezout blade.The procedure was completed successfully.Following the procedure, the patient experienced sciatic nerve palsy.The surgeon indicates that the patient is recovering.

• Brand Name: EZOUT BLADE PACK, 60MM
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPAEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA
• Manufacturer Contact: una barry ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 13902089
• Report Number: 3015967359-2022-00564
• Device Sequence Number: 4596311
• Product Code: HWE
• UDI-Device Identifier: 07613327294408
• UDI-Public: 07613327294408
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2023
• Device Model Number: 7812060001K
• Device Catalogue Number: 7812060001K
• Device Lot Number: 18114017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2022
• Supplement Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 03/25/2022
• Supplement Report FDA Received Date: 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown