MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO AO LARGE REAMER ATTACHEMNT; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	6203210000
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number e2015055.Reported events: 2 events were reported for this quarter.Product return status: 2 devices were received for evaluation.Evaluation status: 2 device evaluations are in progress.Additional information: this device is not labeled for single-use.This device was not reprocessed and reused.
Event or Problem Description
This report summarizes 2 malfunction events in which the device had a component detach.1 event had no patient involvement; no patient impact.1 event had patient involvement; no patient impact.
Event or Problem Description
This report summarizes 2 malfunction events in which the device had a component detach.1 event had no patient involvement; no patient impact.1 event 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 corrected data.2 total events were 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 driveshaft.  additional information 2 devices were not labeled for single-use.2 devices were not reprocessed and reused.

• Brand Name: AO LARGE REAMER ATTACHEMNT
• 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: 8014603
• Report Number: 0001811755-2018-02022
• Device Sequence Number: 13798406
• Product Code: HWE
• UDI-Device Identifier: 04546540501707
• UDI-Public: 04546540501707
• 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): 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 6203210000
• Device Lot Number: E2015055
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/02/2018
• Supplement Date Received by Manufacturer: 06/02/2018
• 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