MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO D59 FOOTED DURAGUARD; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Catalog Number	5400210059
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/28/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device was bent during testing conducted by a manufacturer field service technician at the user facility.No patient involvement, no delay, no medical intervention, and no adverse consequences were reported.

• Brand Name: D59 FOOTED DURAGUARD
• 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: 9147979
• Report Number: 0001811755-2019-03154
• Device Sequence Number: 2665561
• Product Code: ERL
• UDI-Device Identifier: 04546540469212
• UDI-Public: 04546540469212
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: 112593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/02/2019

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: Other
• Device Catalogue Number: 5400210059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2019
• Initial Report FDA Received Date: 10/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1