MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP THIN OFFSET (9.0 X 0.38 X 25.0MM); BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	2296003511
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 july 1 ¿ september 30 2025.This report summarizes 7 events for the failure: fracture.7 events 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.Reported events: 7 events were reported for this quarter.Product return status: 7 devices had investigation types that have not yet been determined.Evaluation findings (results/components): 7 devices: results pending completion of investigation / part/component/sub-assembly term not applicable.Product disposition: 7 devices: product disposition is not yet determined.Additional information: 7 devices were labeled for single-use.7 devices were not reprocessed or reused.
Event or Problem Description
No change.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Mfr report # 3015967359-2025-99494.Supplemental rationale: corrected data: b5, h6, h11.7 previously reported events were included in this follow-up record.Product return status: 3 devices had investigation types that have not yet been determined.2 devices were evaluated based on historical data analysis.2 devices were evaluated using data provided by the user or third party.Evaluation findings (results/components): 3 devices: results pending completion of investigation / part/component/sub-assembly term not applicable.2 devices: fracture problem / part/component/sub-assembly term not applicable.2 devices: fracture problem / mount.Product disposition: 4 devices: product not received.3 devices: product disposition is not yet determined.
Event or Problem Description
No change.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Mfr report # 3015967359-2025-99494.Supplemental rationale: corrected data: b5, h6, h11.7 previously reported events were included in this follow-up record.Product return status 2 devices were received.3 devices were evaluated based on historical data analysis.2 devices were evaluated using data provided by the user or third party.Evaluation findings (results/components) 4 devices: fracture problem / mount.3 devices: fracture problem / part/component/sub-assembly term not applicable.Product disposition 2 devices: archived by stryker.5 devices: product not received.

• Brand Name: THIN OFFSET (9.0 X 0.38 X 25.0MM)
• 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: 23399962
• Report Number: 3015967359-2025-99494
• Device Sequence Number: 15956290
• Product Code: GFA
• UDI-Device Identifier: 04546540046673
• UDI-Public: 04546540046673
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 7
• 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): 04/24/2026

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: 2296003511
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/30/2025
• Supplement Date Received by Manufacturer: 09/30/2025; 09/30/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 01/27/2026; 04/24/2026
• 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