MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP PERFORMANCE SERIES SAGITTAL BLADE (25.0X1.27X90MM); BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number 6125127090

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 11/09/2022

Event Type  malfunction  

Event Description

The user facility reported that a puncture was observed in the packaging of a blade prior to opening.There was no patient involvement, no delay, no adverse consequences or medical intervention were reported.

Manufacturer Narrative

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

Manufacturer Narrative

H6: the quality investigation is complete.

Event Description

The user facility reported that a puncture was observed in the packaging of a blade prior to opening.There was no patient involvement, no delay, no adverse consequences or medical intervention were reported.

• Brand Name: PERFORMANCE SERIES SAGITTAL BLADE (25.0X1.27X90MM)
• 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: 15885995
• MDR Text Key: 304797755
• Report Number: 3015967359-2022-02364
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 04546540501516
• UDI-Public: 04546540501516
• 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,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6125127090
• Device Catalogue Number: 6125127090
• Device Lot Number: 22269037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2022
• 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