MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP PERFORMANCE SERIES SAGITTAL BLADE (25.0X1.27X100MM); BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	6125127100
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Codes	Insufficient Information (4580); 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 january 1 ¿ march 31, 2026.This report summarizes 3 events for the failure: delivered as unsterile product.2 events had problem identified before clinical use/exposure; there was no patient involvement.1 event had insufficient information.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 3 events were reported for this quarter.Product return status: 3 devices were received.Evaluation findings (results/components): 3 devices: no device problem found / part/component/sub-assembly term not applicable.Product disposition: 3 devices: archived by stryker.Additional information: 3 devices were labeled for single-use.3 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.Mfr report # 3015967359-2026-99270.Supplemental rationale: corrected data: b5, h6, h11.3 previously reported events were included in this follow-up record.Product return status: 3 devices were received.Evaluation findings (results/components): 3 devices: no device problem found / part/component/sub-assembly term not applicable.Product disposition: 3 devices: archived by stryker.
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 january 1 ¿ march 31 2026.This report summarizes 3 events for the failure: delivered as unsterile product.- 3 events had problem identified before clinical use/exposure; there was no patient involvement.

• Brand Name: PERFORMANCE SERIES SAGITTAL BLADE (25.0X1.27X100MM)
• 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: 24954310
• Report Number: 3015967359-2026-99270
• Device Sequence Number: 20153156
• Product Code: GFA
• UDI-Device Identifier: 04546540501523
• UDI-Public: 04546540501523
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 3
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2026

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: 6125127100
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/31/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 04/27/2026
• 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