MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PD SERIES MAESTRO D" ATTACHMENT"; MOTOR, DRILL, PNEUMATIC

Catalog Number	5400210056
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/01/2019
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: 4 events were reported for this quarter.Product return status: 4 devices were received.Event confirmation status: 4 device evaluations are still in progress.Additional information: 4 devices were not labeled for single-use.4 devices were not reprocessed and reused.
Event or Problem Description
This report summarizes 4 malfunction events in which the device reportedly overheated.4 events 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: 4 previously reported events are included in this follow-up record.Product return status: 4 devices were received.Event confirmation status: 4 reported events were not confirmed.Evaluation results: 3 devices were found to be affected by internal component corrosion.1 device was found to be affected by internal debris.
Event or Problem Description
This report summarizes 4 malfunction events in which the device reportedly overheated.4 events had no patient involvement; no patient impact.

• Brand Name: PD SERIES MAESTRO D" ATTACHMENT"
• Common Device Name: MOTOR, DRILL, PNEUMATIC
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8546018
• Report Number: 0001811755-2019-01370
• Device Sequence Number: 2319166
• Product Code: HBB
• UDI-Device Identifier: 07613153014010
• UDI-Public: 07613153014010
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 4
• 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): 07/08/2019

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: 5400210056
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/01/2019
• Supplement Date Received by Manufacturer: 01/01/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 07/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1