MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CORE ARIA DRILL; MOTOR, DRILL, PNEUMATIC

Catalog Number	5400210000
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 1 event was reported for this quarter.Product return status: 1 device investigation type has not yet been determined.Additional information: 1 device was not labeled for single-use.1 device was not reprocessed and reused.
Event or Problem Description
This report summarizes 1 malfunction event in which the device was found to be damaged in a manner that could allow for the escape of gas or liquid.1 event had no patient involvement; no patient impact.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale: corrected data: 1 previously reported event is included in this follow-up record.Product return status: 1 device was received.Event confirmation status: 1 reported event was confirmed.Evaluation results: 1 device was found to be affected by the hose assembly separating.
Event or Problem Description
This report summarizes noe 1 /noe malfunction event in which the device was found to be damaged in a manner that could allow for the escape of gas or liquid.1 event had no patient involvement; no patient impact.

• Brand Name: CORE ARIA DRILL
• Common Device Name: MOTOR, DRILL, PNEUMATIC
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8816128
• Report Number: 0001811755-2019-02376
• Device Sequence Number: 14239690
• Product Code: HBB
• UDI-Device Identifier: 07613154499991
• UDI-Public: 07613154499991
• 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,Followup
• Report Date (Section B): 10/03/2019

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: 5400210000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/24/2019
• Supplement Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 10/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1