MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PD SERIES MAESTRO STEERING DURAGUARD; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Catalog Number	5400210257
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the blade sheath broke off during a procedure.The broken component during a procedure could result in damage to the dura requiring medical intervention.There was no patient impact and the procedure was completed successfully.Attempts were made to obtain additional information about the event; no further information was received.
Event or Problem Description
The user facility reported that the blade sheath broke off during a procedure.The broken component during a procedure could result in damage to the dura requiring medical intervintion.There was no patient impact and the procedure was completed successfully.Attempts were made to obtain additional information about the event; no further information was received.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.

• Brand Name: PD SERIES MAESTRO STEERING 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: 8709755
• Report Number: 0001811755-2019-02075
• Device Sequence Number: 16605429
• Product Code: ERL
• UDI-Device Identifier: 04546540469267
• UDI-Public: 04546540469267
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K112593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2019

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: Health Professional
• Device Catalogue Number: 5400210257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Initial Date Received by Manufacturer: 06/11/2019
• Supplement Date Received by Manufacturer: 10/14/2019
• Initial Report FDA Received Date: 06/18/2019
• Supplement Report FDA Received Date: 10/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1