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

Catalog Number	5100120952
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Patient Involvement (2645)
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: 3 events were reported for this quarter.Product return status: 1 device was received for evaluation; 2 device was available for evaluation but has not yet been received.Evaluation status: 1 event was confirmed during testing; 1 device was found to be affected by corrosion.Product disposition: this device is not repairable and was not returned to the user facility.Additional information: there were no remedial actions taken.This device is not labeled for single-use.
Event or Problem Description
This report summarizes 3 malfunction events in which the device reportedly overheated.The 3 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: 3 total events were initially reported.2 previously reported events are included in this follow-up record.Product return status 2 devices were received.Evaluation status confirmed 2 reported events were confirmed during testing.- 2 devices were found to be affected by widespread corrosion.Additional information 3 devices were not labeled for single-use.3 devices were not reprocessed and reused.
Event or Problem Description
This report summarizes 3 malfunction events in which the device reportedly overheated.3 events had no patient involvement; no patient impact.

• Brand Name: SD/PD SERIES MIS LONG 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: 7714995
• Report Number: 0001811755-2018-01270
• Device Sequence Number: 1065240
• Product Code: ERL
• UDI-Device Identifier: 04546540494795
• UDI-Public: 04546540494795
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 3
• 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: 5100120952
• 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