MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SYSTEM 6 BATTERY; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	6215000000
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/25/2018
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: 3 devices were received.Evaluation status: in progress 3 device evaluations are in progress.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 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: 3 events were previously reported during the reporting quarter; however: - 1 previously reported event was included under mfr report # 0001811755-2019-00359 but should be included under this report.- 4 total events were reported for this catalog number/device code combination for the reporting quarter.- 4 previously reported events are included in this follow-up record.  product return status 4 devices were received.Event confirmation status 4 reported events were not confirmed.Evaluation results 4 devices had no device problem found.
Event or Problem Description
This report summarizes 4 malfunction events in which the device was reportedly leaking.4 events had patient involvement; no patient impact.

• Brand Name: SYSTEM 6 BATTERY
• 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: 8284731
• Report Number: 0001811755-2019-00258
• Device Sequence Number: 1307033
• Product Code: HWE
• UDI-Device Identifier: 04546540501851
• UDI-Public: 04546540501851
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 4
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2019

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: 6215000000
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/25/2018
• Supplement Date Received by Manufacturer: 12/25/2018
• Initial Report FDA Received Date: 01/29/2019
• Supplement Report FDA Received Date: 06/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1