MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PD SERIES MAESTRO ANGLED LONG "AM" ATTACHMENT; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Model Number	5400210072
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/12/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that a screw fell out of the device.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.
Additional Manufacturer Narrative
Follow-up report submitted to document device evaluation results.
Event or Problem Description
The user facility reported that a screw fell out of the device.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.

• Brand Name: PD SERIES MAESTRO ANGLED LONG "AM" 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: 9419280
• Report Number: 0001811755-2019-03975
• Device Sequence Number: 14066166
• Product Code: ERL
• UDI-Device Identifier: 04546540555755
• UDI-Public: 04546540555755
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: 112593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2020

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 Model Number: 5400210072
• Device Catalogue Number: 5400210072
• Device Lot Number: 16112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 05/04/2020
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 05/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1