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 Codes	Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
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: 1 event was reported for this quarter.Product return status: 1 device was received.Evaluation status: 1 device evaluation is in progress.Additional information: 1 device is not labeled for single-use.1 device was not reprocessed and reused.
Event or Problem Description
This report summarizes 1 malfunction event in which the device was reportedly leaking and disassembled.1 event 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: - 1 event for fluid leak (1250) and detachment of device or device component (2907) was previously reported during the reporting period; however, - 1 previously reported event for detachment of device or device component (2907) in this report was reported in error.- 1 previously reported event for fluid leak (1250) in this report will be summarized under mfr report # 0001811755-2019-00258.- 0 previously reported events for both fluid leak (1250) and detachment of device or device component (2907) are included in this follow-up record.
Event or Problem Description
This report summarizes 0 malfunction event in which the device was reportedly leaking and disassembled.0 event had no 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: 8285062
• Report Number: 0001811755-2019-00359
• Device Sequence Number: 1616742
• Product Code: HWE
• UDI-Device Identifier: 04546540501851
• UDI-Public: 4546540501851
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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