MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP PERFORMANCE SERIES SAGITTAL BLADE (18.0X1.27X90MM); BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number 6118127090

Device Problem Fracture (1260)

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

Event Date 09/30/2023

Event Type  malfunction  

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events.4 events were reported for this quarter.Product return status.4 devices were evaluated based on historical data analysis.Additional information.4 devices were labeled for single-use.4 devices were not reprocessed or reused.

Event Description

This report summarizes 4 malfunction events in which the device or cutting accessory fractured.1 event had no patient involvement; no patient impact.3 events had patient involvement; no patient impact.

• Brand Name: PERFORMANCE SERIES SAGITTAL BLADE (18.0X1.27X90MM)
• 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: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 17992799
• MDR Text Key: 326365185
• Report Number: 3015967359-2023-02269
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 04546540501417
• UDI-Public: 04546540501417
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 4
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 6118127090
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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