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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events- 5 events were reported for this quarter.Product return status- 1 device was received.4 devices had investigation types that have not yet been determined.Additional information- 5 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 5 events for the failure: fracture.- 4 events had no health consequences or impact.- 1 event had problem identified before clinical use/exposure; there was no patient involvement.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Mfr report # 3015967359-2025-99134.Supplemental rationale, corrected data: b5, h6, h11.5 previously reported events were included in this follow-up record.Product return status.3 devices were evaluated based on historical data analysis.2 devices had investigation types that have not yet been determined.Evaluation findings (results/components).3 devices: fracture problem / part/component/sub-assembly term not applicable.2 devices: results pending completion of investigation / part/component/sub-assembly term not applicable.Product disposition.3 devices: product not received.2 devices: product disposition is not yet determined.
Event or Problem Description
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Events occurred between april 1 ¿ june 30, 2025.This report summarizes 5 events for the failure: fracture.- 4 events had no health consequences or impact.- 1 event had problem identified before clinical use/exposure; there was no patient involvement.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Mfr report # 3015967359-2025-99134.Supplemental rationale.Corrected data: b5, h6, h11.5 previously reported events were included in this follow-up record.Product return status.4 devices were evaluated based on historical data analysis.1 device was received.Evaluation findings (results/components).4 devices: fracture problem / part/component/sub-assembly term not applicable.1 device: fracture problem / mount.Product disposition.4 devices: product not received.1 device: archived by stryker.
Event or Problem Description
No change.

• 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: 22646729
• Report Number: 3015967359-2025-99134
• Device Sequence Number: 8677744
• 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: 5
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/29/2026

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/30/2025
• Supplement Date Received by Manufacturer: 06/30/2025; 06/30/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 10/30/2025; 01/29/2026
• 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