MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO TPS UNIVERSAL HANDSWITCH; UNIT, OPERATIVE DENTAL

Catalog Number 5100009000

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/02/2018

Event Type  malfunction  

Manufacturer Narrative

This mdr is part of the malfunction summary reporting program, exemption number e2015055.Reported events: 3 events were reported for this quarter.Product return status: 3 devices were received for evaluation.Evaluation status: 3 events were confirmed during testing, 3 devices were found to be affected by part of the bottom lever missing.Product disposition: these devices are not repairable and were not returned to the user facility.Additional information, there were no remedial actions taken on this device.This device is not labeled for single-use.

Event Description

This report summarizes 3 malfunction events in which the device had small pieces breaking off.3 events had no patient involvement; no patient impact.

• Brand Name: TPS UNIVERSAL HANDSWITCH
• Type of Device: UNIT, OPERATIVE DENTAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: zach baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 7714812
• MDR Text Key: 115215408
• Report Number: 0001811755-2018-01206
• Device Sequence Number: 1
• Product Code: EIA
• UDI-Device Identifier: 04546540074393
• UDI-Public: 04546540074393
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 3
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 5100009000
• Device Lot Number: E2015055
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1