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	Break (1069)
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: 1 event was reported for this quarter.Product return status: 1 device was received for evaluation.Evaluation status: event was confirmed during testing.Device was found to be affected by a wear problem.Product disposition: this device is not repairable and was not returned to the user facility.Additional information there were no remedial actions taken on this device.This device is not labeled for single-use.
Event or Problem Description
This report summarizes 1 malfunction event in which the device had a broken cutting accessory still attached.One event 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: 7714819
• Report Number: 0001811755-2018-01230
• Device Sequence Number: 13719528
• 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: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/24/2018

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2018
• Initial Report FDA Received Date: 07/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1