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

Catalog Number	6126120000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number e2015055.Reported events: 5 events were reported for this quarter.Product return status: 2 devices were received for evaluation; 3 devices were available for evaluation but have not yet been received.Evaluation status: 1 event was confirmed during testing; 1 device was found to be affected by a fracture problem; 1 device evaluation is in progress.Product disposition: this device is not repairable and was not returned to the user facility.Additional information: there were no remedial actions taken.This device is not labeled for single-use.
Event or Problem Description
This report summarizes 5 malfunction events in which the device had a condition in which the non-sterile battery had the potential to be exposed to the surgical site.The 2 events had no patient involvement; no patient impact.The 3 events had patient involvement; no patient impact.
Additional Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number e2015055.Supplemental rationale: 4 previously reported events are included in this follow-up record.  product return status: 2 devices were received for evaluation.1 device was not available to stryker for evaluation.  evaluation status: 3 reported events were confirmed during testing.3 devices were found to be affected by a fracture problem.  4 devices were not labeled for single-use.4 devices were not reprocessed and reused.
Event or Problem Description
This report summarizes 5 malfunction events in which the device had a condition in which the non-sterile battery had the potential to be exposed to the surgical site.2 events had no patient involvement; no patient impact.3 events had patient involvement; no patient impact.

• Brand Name: SYSTEM 6 ASEPTIC HOUSING
• 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: 7715062
• Report Number: 0001811755-2018-01303
• Device Sequence Number: 1120288
• Product Code: HWE
• UDI-Device Identifier: 04546540501578
• UDI-Public: 04546540501578
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 5
• 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): 10/29/2018

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: 6126120000
• Device Lot Number: E2015055
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/02/2018
• Supplement Date Received by Manufacturer: 03/02/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 10/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1