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 Sticking (1597); Positioning Problem (3009)

Patient Problem No Patient Involvement (2645)

Event Date 06/02/2017

Event Type  malfunction  

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program, exemption number (b)(4).Twenty three events were reported for this quarter.Twenty two devices were received for evaluation.Twenty events were duplicated during testing.The event was not duplicated during testing for 1 device; however, the device was found to be out of specification.Ten devices were found to be affected by corrosion.Eleven devices were found to be affected by corrosion.One device evaluation is in progress.One device was not available to stryker for evaluation.There were no remedial actions taken.The devices are not labeled for single-use.

Event Description

This report summarizes 23 malfunction events in which the device had a sticky trigger.Twenty two reported events had no patient involvement; no patient impact.One reported event had 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: 2 previously reported events are included in this follow-up record.Product return status: 2 devices were received for evaluation.Evaluation status: 2 events were confirmed during testing.1 device was found to be affected by corrosion.1 device was found to be affected by a faulty drive train, motor unit, and damaged handle.Additional information: 2 devices were not labeled for single-use.2 devices were not reprocessed and reused.

Event Description

This report summarizes 23 malfunction events in which the device had a sticky trigger.22 reported events had no patient involvement; no patient impact.1 reported event had patient involvement; no patient impact.

• 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
• 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: 6981725
• MDR Text Key: 91189499
• Report Number: 0001811755-2017-02268
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 23
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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