MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO F1 OSC SAW; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	1900031000
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/24/2019
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: 3 events were reported for this quarter.Product return status: 2 devices were received.1 device was not available for evaluation.Event confirmation status: 1 reported event was confirmed.1 reported event was not confirmed.Evaluation results: 1 device was found to be affected by internal component corrosion.1 device had no problem found.Additional information: 3 devices were not labeled for single-use.3 devices were not reprocessed and reused.
Event or Problem Description
This report summarizes 3 malfunction events in which the device was reportedly leaking.3 events had no patient involvement; no patient impact.

• Brand Name: F1 OSC 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: 8816159
• Report Number: 0001811755-2019-02408
• Device Sequence Number: 2838814
• Product Code: HWE
• UDI-Device Identifier: 07613327071979
• UDI-Public: 07613327071979
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/23/2019

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: 1900031000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 07/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1