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

Catalog Number	6206000000
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
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 are not labeled for single-use.4 devices are not reprocessed and reused.
Event or Problem Description
This report summarizes 4 malfunction event in which the device had a component detach.4 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: 4 total events were initially reported.4 previously reported events are included in this follow-up record.  product return status 4 devices were received.Event confirmation status 4 reported events were confirmed; the cause traced to component failure.Evaluation results 4 devices were found to be affected by a missing component.
Event or Problem Description
This report summarizes 4 malfunction event in which the device had a component detach.4 event had no patient involvement; no patient impact.

• Brand Name: SYSTEM 6 RECIP
• 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: 8014217
• Report Number: 0001811755-2018-01922
• Device Sequence Number: 1352824
• Product Code: HWE
• UDI-Device Identifier: 07613154392360
• UDI-Public: 07613154392360
• 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): 04/25/2019

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: 6206000000
• 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: 04/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1