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

Model Number 8208000000

Device Problem Fluid/Blood Leak (1250)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/30/2020

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: 1 event was reported for this quarter.Product return status: 1 device investigation type has not yet been determined.1 device was not labeled for single-use.1 device was not reprocessed or reused.

Event Description

This report summarizes 1 malfunction event in which the device was reportedly leaking.1 event had no 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: 1 previously reported event is included in this follow-up record.Product return status: 1 device was received.Event confirmation status: 1 reported event was confirmed.Evaluation results: 1 device did not have a root cause established.

Event Description

This report summarizes 1 malfunction event in which the device was reportedly leaking.1 event had no 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-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 10329806
• MDR Text Key: 200775273
• Report Number: 0001811755-2020-01880
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07613327304541
• UDI-Public: 07613327304541
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8208000000
• Device Catalogue Number: 8208000000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1