MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SD/PD SERIES MIS MEDIUM CURVED ATTACHMENT; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Catalog Number	5100120922
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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.Evaluation status - 1 event was confirmed during testing.- 1 device was found to be affected by a lack of lubrication.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 reportedly overheated.2 events had 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: 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 1 reported event was confirmed during testing.- 1 device was found to be affected by a lubrication problem.  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 reportedly overheated.2 events had no patient involvement; no patient impact.

• Brand Name: SD/PD SERIES MIS MEDIUM CURVED ATTACHMENT
• Common Device Name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8014628
• Report Number: 0001811755-2018-02065
• Device Sequence Number: 19242635
• Product Code: ERL
• UDI-Device Identifier: 04546540494771
• UDI-Public: 04546540494771
• 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 an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 5100120922
• 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