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

Catalog Number	8208000000
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2024
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: 39 events were reported for this quarter.Product return status: 11 devices were received.24 devices were not available for evaluation.4 device investigation types have not yet been determined.Additional information: 39 devices were not labeled for single-use.39 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 39 malfunction events in which the device was reportedly leaking.30 events had the problem identified during a non-clinical procedure; there was no patient involvement.2 events had the problem identified before clinical use/exposure; there was no patient involvement.7 events had patient involvement: no patient 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, h6, h11 39 previously reported events are included in this follow-up record.Product return status 12 devices were received.24 devices were not available for evaluation.3 device investigation types have not yet been determined.
Event or Problem Description
This report summarizes 39 malfunction events in which the device was reportedly leaking.- 30 events had the problem identified during a non-clinical procedure; there was no patient involvement.- 2 events had the problem identified before clinical use/exposure; there was no patient involvement.-7 events had patient involvement; no patient 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 39 events were previously reported during the reporting quarter; however, 1 event was reported in error.38 previously reported events are included in this follow-up record.Product return status 14 devices were received.24 devices were not available for evaluation.
Event or Problem Description
This report summarizes 38 malfunction events in which the device was reportedly leaking.29 events had the problem identified during a non-clinical procedure; there was no patient involvement.2 events had the problem identified before clinical use/exposure; there was no patient involvement.7 events had patient involvement; no patient impact.

• Brand Name: SYSTEM 8 SAGITTAL 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: 21201047
• Report Number: 3015967359-2025-00217
• Device Sequence Number: 7559558
• Product Code: HWE
• UDI-Device Identifier: 07613327304541
• UDI-Public: 07613327304541
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 38
• 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): 04/23/2025

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: 8208000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/31/2024
• Supplement Date Received by Manufacturer: 12/31/2024; 12/31/2024
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 01/30/2025; 04/23/2025
• 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