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 Codes	No Patient Involvement (2645); No Information (3190)
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: 2 events were reported for this quarter.Product return status: 1 device was received for evaluation.1 device was available for evaluation but has not yet been received.Evaluation status: 1 device evaluation is in progress.Additional information: 2 devices were not labeled for single-use.2 devices were not reprocessed and reused.
Event or Problem Description
This report summarizes 2 malfunction events in which the device fractured.1 event had no patient involvement; no patient impact.1 event had no information received.
Event or Problem Description
This report summarizes 2 malfunction events in which the device fractured.1 event had no patient involvement; no patient impact.1 event had no information received.
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: 2 total events were initially reported.2 previously reported events are included in this follow-up record.  product return status 2 devices were received.  event confirmation status 2 reported events were confirmed; the cause traced to component failure.Evaluation results 2 devices were found to be affected by a fracture.

• 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: 8014447
• Report Number: 0001811755-2018-01979
• Device Sequence Number: 13795356
• 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: 2
• 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): 04/12/2019

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: 6126120000
• 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: 04/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1