MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP PERFORMANCE SERIES SAGITTAL BLADE (13.0X1.27X90MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Model Number 6113127090

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/06/2021

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be filed once the quality investigation is complete.

Event Description

It was reported that during a total knee procedure, the blade broke at the mount.It was also reported that the broken piece was removed from the patient and there was a two minute delay as a result of this event.It was further reported that there were no adverse consequences as a result of this event and the procedure was completed successfully.

• Brand Name: PERFORMANCE SERIES SAGITTAL BLADE (13.0X1.27X90MM)
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL
• 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: 13061456
• MDR Text Key: 282629797
• Report Number: 3015967359-2021-02768
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 04546540501356
• UDI-Public: 04546540501356
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/22/2021

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
• Device Operator: Health Professional
• Device Model Number: 6113127090
• Device Catalogue Number: 6113127090
• Device Lot Number: 21222027
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/06/2021
• Initial Date FDA Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1