MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP EZOUT BLADE PACK, 48MM; DRILLS, BURRS, TREPHINES & ACCESSORIES

Model Number	7812048001K
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a revision total hip arthroplasty(tha) surgical procedure, it was noted that the blade broke.It was also reported there were no delays, no adverse consequences or medical intervention as a result of this event.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting for device return to manufacturer.
Additional Manufacturer Narrative
H6: the quality investigation is complete.
Event or Problem Description
It was reported that during a revision total hip arthroplasty(tha) surgical procedure, it was noted that the blade broke.It was also reported there were no delays, no adverse consequences or medical intervention as a result of this event.It was further reported that the procedure was completed successfully.

• Brand Name: EZOUT BLADE PACK, 48MM
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES
• 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: 15904024
• Report Number: 3015967359-2022-02374
• Device Sequence Number: 12203011
• Product Code: HWE
• UDI-Device Identifier: 07613327294439
• UDI-Public: 07613327294439
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2023

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 Model Number: 7812048001K
• Device Catalogue Number: 7812048001K
• Device Lot Number: 21315017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2022
• Supplement Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 12/02/2022
• Supplement Report FDA Received Date: 02/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2021
• 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
• Patient Sex: Unknown