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

Catalog Number	4300034000
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number e2015055.Reported events: 2 events were reported for this quarter.Product return status: 2 devices were received for evaluation.Evaluation status: 1 event was not confirmed during testing, 1 event was confirmed during testing, - 1 device was unable to have a cause established.Product disposition: 2 devices were repaired and returned to the account.Additional information: there were no remedial actions taken.This device is not labeled for single-use.
Event or Problem Description
This report summarizes 2 malfunction events in which the device was reportedly leaking; 1 event had no patient involvement; no patient impact; 1 event had patient involvement; no patient impact.

• Brand Name: SABO SAGITTAL SAW
• Common Device Name: 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: 7714974
• Report Number: 0001811755-2018-01255
• Device Sequence Number: 11095219
• Product Code: HWE
• UDI-Device Identifier: 07613154705078
• UDI-Public: 07613154705078
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/24/2018

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
• Operator of Device: No Information
• Device Catalogue Number: 4300034000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2018
• Initial Report FDA Received Date: 07/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1