MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP PERFORMANCE SERIES SAGITTAL BLADE (18.0X0.97X90MM); BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	6118097090
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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 (b)(6) 2025.This report summarizes 1 event for the failure: fracture.1 event had no health consequences or impact.
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 1 event was previously reported during the reporting quarter; however, 1 previously reported event was included under mfr report # 3015967359-2026-99073 but should be included under this report.1 previously reported events are included in this follow-up record.Product return status: 1 device was not available for evaluation.Evaluation findings (results/components): 1 device: no findings available / part/component/sub-assembly term not applicable.Product disposition: 1 device: product not received.

• Brand Name: PERFORMANCE SERIES SAGITTAL BLADE (18.0X0.97X90MM)
• 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: 24911747
• Report Number: 3015967359-2026-99190
• Device Sequence Number: 21110009
• Product Code: GFA
• UDI-Device Identifier: 04546540501394
• UDI-Public: 04546540501394
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/17/2026

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: 6118097090
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/31/2025
• Initial Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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