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

Catalog Number	6126000000
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: one event was reported for this quarter.Product return status: one device was available for evaluation but has not yet been received.Additional information: there were no remedial actions taken.This device is not labeled for single-use.
Event or Problem Description
This report summarizes 1 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.There was no patient involvement; no patient impact.
Additional Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number e2015055.  supplemental rationale corrected data: 1 event was initially reported.1 previously reported event is included in this follow-up record.  product return status 1 device was received.Evaluation status confirmed 1 reported event was confirmed during testing.- 1 device was found to be affected by a fractured hinge.  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 events in which the device had a condition in which the non-sterile battery had the potential to be exposed to the surgical site.There was no patient involvement; no patient impact.

• Brand Name: SYSTEM 6 ASEPTIC BATTERY KIT
• 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: 7715066
• Report Number: 0001811755-2018-01301
• Device Sequence Number: 1120834
• Product Code: HWE
• UDI-Device Identifier: 04546540501554
• UDI-Public: 04546540501554
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• 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: 6126000000
• 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: 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1