MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO REMB ELECTRIC HAND SWITCH; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Catalog Number	6400009000
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number e2015055. reported events: two events were reported for this quarter.Product return status: two devices were received for evaluation.Evaluation status: two device evaluations are in progress.Additional information: there were no remedial actions taken.This device is not labeled for single-use.
Event or Problem Description
This report summarizes 2 malfunction events in which the device was reportedly leaking.Two events had no patient involvement; no patient impact.
Additional Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number e2015055.Supplemental rationale corrected data: 2 total events were initially reported.2 previously reported events are included in this follow-up record.  product return status 2 devices were received.  evaluation status not confirmed 2 reported events were not confirmed during testing; however: - 2 devices were found to be affected by a split weld.  additional information 2 devices were not labeled for single-use.2 devices were not reprocessed and reused.
Event or Problem Description
This report summarizes 2 malfunction events in which the device was reportedly leaking.2 events had no patient involvement; no patient impact.

• Brand Name: REMB ELECTRIC HAND SWITCH
• 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: 7715534
• Report Number: 0001811755-2018-01526
• Device Sequence Number: 1076116
• Product Code: ERL
• UDI-Device Identifier: 07613154938230
• UDI-Public: 7613154938230
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 2
• 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): 01/31/2019

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: 6400009000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/02/2018
• Supplement Date Received by Manufacturer: 03/02/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1