MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SYSTEM 8 STERNUM SAW; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	8207000000
Medical Device Problem Code	Unintended Power Up (1162)
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 15 events were reported for this quarter.Product return status 14 devices had investigation types that have not yet been determined.1 device was received.Additional information 15 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 15 events for the failure: unintended power up.- 15 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.Mfr report # 3015967359-2025-99139.Supplemental rationale, corrected data: b5, h1, h6, h11.15 events were previously reported during the reporting quarter: however, - 14 events were reported in error.- 1 previously reported event is included in this follow-up record.Product return status, 1 device was received.Evaluation findings (results/components), 1 device: no device problem found / part/component/sub-assembly term not applicable.Product disposition, 1 device: serviced and returned to customer.
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 1 event for the failure: unintended power up.- 1 event had no health consequences or impact.
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 # 3015967359-2025-99139.Supplemental rationale corrected data: b5, h6, h11 1 previously reported event was included in this follow-up record.Product return status 1 device was received.Evaluation findings (results/components) 1 device: no device problem found / part/component/sub-assembly term not applicable product disposition 1 device: serviced and returned to customer.

• Brand Name: SYSTEM 8 STERNUM SAW
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: kelsey barla ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 22647003
• Report Number: 3015967359-2025-99139
• Device Sequence Number: 21038548
• Product Code: HWE
• UDI-Device Identifier: 07613327304398
• UDI-Public: 07613327304398
• 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,Followup,Followup
• Report Date (Section B): 04/29/2026

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: 8207000000
• 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: 10/31/2025; 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown