MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO ELECTRIC SYSTEM 6 SINGLE TRIGGER ROTARY HANDPIECE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number 6293000000

Device Problem Disassembly (1168)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2017

Event Type  malfunction  

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program, exemption number e2015055.Two events were reported for this quarter.One device was received for evaluation.One event was confirmed during testing.One device was found to be affected by disassembly and missing components.One device was available for evaluation but has not yet been received.There were no remedial actions taken.This device is not labeled for single-use.

Event Description

This report summarizes 2 malfunction events in which the device disassembled.Two events had no patient involvement; no patient impact.

Event Description

This report summarizes 2 malfunction events in which the device disassembled.2 events had no patient involvement; no patient impact.

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program, exemption number e2015055.    supplemental rationale: corrected data: 1 previously reported event is included in this follow-up record.Product return status: 1 device was received for evaluation.  evaluation status: 1 reported event was confirmed during testing.1 device was found to be affected by a broken trigger assembly.  additional information: 1 device is not labeled for single-use.1 device was not reprocessed and reused.

• Brand Name: ELECTRIC SYSTEM 6 SINGLE TRIGGER ROTARY HANDPIECE
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7466898
• MDR Text Key: 107225490
• Report Number: 0001811755-2018-00823
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Number of Events Reported: 2
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 6293000000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/02/2017
• Initial Date FDA Received: 04/26/2018
• Supplement Dates Manufacturer Received: 12/02/2017
• Supplement Dates FDA Received: 10/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1