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

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/31/2023

Event Type  malfunction  

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 13 events were reported for this quarter.Product return status: 13 device investigation types have not yet been determined.Additional information: 13 devices were not labeled for single-use.13 devices were not reprocessed or reused.

Event Description

This report summarizes 13 malfunction events in which the device was reportedly leaking.10 events had no patient involvement.No patient impact.3 events had patient involvement.No patient impact.

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: h6, h11 13 previously reported events are included in this follow-up record.Product return status 3 devices were received.1 device was not available for evaluation.9 device investigation types have not yet been determined.

Event Description

This report summarizes 13 malfunction events in which the device was reportedly leaking.- 10 events had no patient involvement; no patient impact.- 3 events had patient involvement; no patient impact.

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: h6, h11 13 previously reported events are included in this follow-up record.Product return status 12 devices were received.1 device was not available for evaluation.

Event Description

This report summarizes 13 malfunction events in which the device was reportedly leaking.- 10 events had no patient involvement; no patient impact.- 3 events had patient involvement; no patient impact.

• Brand Name: SYSTEM 8 SAGITTAL SAW
• Type of Device: 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: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 18556404
• MDR Text Key: 333402242
• Report Number: 3015967359-2024-00167
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07613327304541
• UDI-Public: 07613327304541
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 13
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 8208000000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1