MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP PERFORMANCE SERIES SAGITTAL BLADE (18.0X1.27X100MM); BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	6118127100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes 17 malfunction events in which the device or cutting accessory fractured.15 events had patient involvement; no patient impact.2 events had insufficient information received.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 17 events were reported for this quarter.Product return status: 7 devices were evaluated based on historical data analysis.10 device investigation types have not yet been determined.Additional information: 17 devices were labeled for single-use.17 devices were not reprocessed or reused.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale corrected data: b5, h1, h6, h11 17 events were previously reported during the reporting quarter; however, - 2 events were reported in error.- 15 previously reported events are included in this follow-up record.Product return status 3 devices were received.7 devices were evaluated based on historical data analysis.5 device investigation types have not yet been determined.
Event or Problem Description
This report summarizes 15 malfunction events in which the device or cutting accessory fractured.- 13 events had patient involvement; no patient impact.- 1 event had insufficient information received.- 1 event required imaging.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale corrected data: h6, h11 15 previously reported events are included in this follow-up record.Product return status 4 devices were received.10 devices were evaluated based on historical data analysis.1 device investigation type has not yet been determined.
Event or Problem Description
This report summarizes 15 malfunction events in which the device or cutting accessory fractured.- 12 events had patient involvement; no patient impact.- 3 event required imaging.
Event or Problem Description
This report summarizes 14 malfunction events in which the device or cutting accessory fractured.11 events had patient involvement; no patient impact.3 event required imaging.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale: corrected data: b5, h1, h6, h11.15 events were previously reported during the reporting quarter; however, 1 event was reported in error.14 previously reported events are included in this follow-up record.Product return status: 4 devices were received.9 devices were evaluated based on historical data analysis.1 device investigation type has not yet been determined.
Event or Problem Description
This report summarizes 14 malfunction events in which the device or cutting accessory fractured.- 11 events had patient involvement; no patient impact.- 3 event required imaging.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale corrected data: b5, h6, h11 14 previously reported events are included in this follow-up record.Product return status 4 devices were received.10 devices were evaluated based on historical data analysis.

• Brand Name: PERFORMANCE SERIES SAGITTAL BLADE (18.0X1.27X100MM)
• Common Device Name: 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: kelsey barla ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 21201195
• Report Number: 3015967359-2025-00239
• Device Sequence Number: 15564141
• Product Code: GFA
• UDI-Device Identifier: 04546540501424
• UDI-Public: 04546540501424
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 14
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/28/2025

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 Catalogue Number: 6118127100
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/31/2024
• Supplement Date Received by Manufacturer: 12/31/2024; 12/31/2024; 12/31/2024; 12/31/2024
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 04/23/2025; 04/28/2025; 04/30/2025; 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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