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

Catalog Number	1900099000
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: 8 events were reported for this quarter.Product return status: 3 devices were received.2 devices were not available for evaluation.3 device investigation type has not yet been determined.Event confirmation status: 3 reported events were not confirmed.Evaluation results: 3 devices had no problem found.Additional information: 8 devices were not labeled for single-use.8 devices were not reprocessed and reused.
Event or Problem Description
This report summarizes 8 malfunction events in which the device was reportedly leaking.8 events had no 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: 8 previously reported events are included in this follow-up record.Product return status 4 devices were received.2 devices were not available for evaluation.2 device investigation types have not yet been determined.Event confirmation status 1 reported event was confirmed.3 reported events were not confirmed.Evaluation results 3 devices had no problem found.1 device did not have a root cause established.
Event or Problem Description
This report summarizes 8 malfunction events in which the device was reportedly leaking.8 events had no patient involvement; no patient impact.
Event or Problem Description
This report summarizes 8 malfunction events in which the device was reportedly leaking.8 events had no 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: h10 8 previously reported events are included in this follow-up record.Product return status 4 devices were received.4 devices were not available for evaluation.Event confirmation status 1 reported event was confirmed.3 reported events were not confirmed.Evaluation results 3 devices had no problem found.1 device did not have a root cause established.

• Brand Name: F1 U-DRIVER
• 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: 8816168
• Report Number: 0001811755-2019-02426
• Device Sequence Number: 2417161
• Product Code: HWE
• UDI-Device Identifier: 07613327072037
• UDI-Public: 07613327072037
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 8
• 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): 01/06/2020

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: 1900099000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/24/2019
• Supplement Date Received by Manufacturer: 06/24/2019; 06/24/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 10/28/2019; 01/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1