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	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/01/2018
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 : 4 events were reported for this quarter.  product return status : 4 devices were received for evaluation.  evaluation status : 4 device evaluations are in progress.  additional information : 4 devices were not labeled for single-use.4 devices were not reprocessed and reused.
Event or Problem Description
This report summarizes 4 malfunction events in which the device fractured.4 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: 4 total events were initially reported.4 previously reported events are included in this follow-up record.  product return status 4 devices were received.  evaluation status confirmed 4 reported events were confirmed during testing.- 4 devices were found to be affected by a cracked battery housing.  additional information 4 devices were not labeled for single-use.4 devices were not reprocessed and reused.
Event or Problem Description
This report summarizes 4 malfunction events in which the device fractured.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: 8014422
• Report Number: 0001811755-2018-01994
• Device Sequence Number: 11111586
• 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): 01/31/2019

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: 09/01/2018
• Supplement Date Received by Manufacturer: 09/01/2018
• Initial Report FDA Received Date: 10/29/2018
• Supplement Report FDA Received Date: 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1