MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP PERFORMANCE SERIES SAGITTAL BLADE (13.0X1.27X75.0MM ); BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number 6113127075

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 11/09/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The user facility reported that a hair was observed in the packaging of a blade prior to opening.The procedure was completed successfully without a delay; no adverse consequences or medical intervention were reported.

Event Description

The user facility reported that a hair was observed in the packaging of a blade prior to opening.The procedure was completed successfully without a delay; no adverse consequences or medical intervention were reported.

Manufacturer Narrative

H6: the quality investigation is complete.

• Brand Name: PERFORMANCE SERIES SAGITTAL BLADE (13.0X1.27X75.0MM )
• 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: 15886000
• MDR Text Key: 307572225
• Report Number: 3015967359-2022-02363
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 04546540593313
• UDI-Public: 04546540593313
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/11/2023

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
• Device Operator: Health Professional
• Device Model Number: 6113127075
• Device Catalogue Number: 6113127075
• Device Lot Number: 22269017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/09/2022
• Initial Date FDA Received: 11/30/2022
• Supplement Dates Manufacturer Received: 01/05/2023
• Supplement Dates FDA Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2022
• 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