MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SYSTEM 7 DUAL TRIGGER ROTARY HANDPIECE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number 7205000000

Device Problems Device Remains Activated (1525); Sticking (1597)

Patient Problem No Patient Involvement (2645)

Event Date 09/02/2017

Event Type  malfunction  

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program, exemption number (b)(4).28 events were reported for this quarter.23 devices were received for evaluation; 10 events were confirmed during testing.6 devices were found to be affected by corrosion.4 devices were found to be affected by a trigger assembly that was damaged and catching in the device.13 device evaluations are in progress.5 devices are available for evaluation but have not yet been received.There were no remedial actions taken.This device is not labeled for single-use.

Event Description

This report summarizes 28 malfunction events in which the device had a sticky trigger.28 events had no patient involvement; no patient impact.

Event Description

This report summarizes 28 malfunction events in which the device had a sticky trigger.28 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: 18 previously reported events are included in this follow-up record.  product return status: 17 devices were received for evaluation.1 device was not available to stryker for evaluation.  evaluation status: confirmed.16 reported events were confirmed during testing. 6 devices were found to be affected by corrosion.7 devices were found to be affected by a worn/damaged trigger.3 devices were found to be affected by debris.1 reported event was not confirmed during testing; the device was found to be within specifications.  additional information: 18 devices were not labeled for single-use.18 devices were not reprocessed and reused.

• Brand Name: SYSTEM 7 DUAL 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: 7220190
• MDR Text Key: 98434937
• Report Number: 0001811755-2018-00340
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Number of Events Reported: 28
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 7205000000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/02/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1