MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO WIRE COLLET (.7-1.8MM); ARTHROSCOPE

Catalog Number 4100062000

Device Problem Metal Shedding Debris (1804)

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).8 events were reported for this quarter.7 devices were received for evaluation.7 events were confirmed.7 devices were found to be affected by corrosion.This device is not repairable and was not returned to the user facility.1 device is 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 8 malfunction events, in which the device had metal shavings.8 reported 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 event was confirmed during testing.1 device was found to be affected by metal shavings.Additional information: 1 device is not labeled for single-use.1 device was not reprocessed and reused.

Event Description

This report summarizes 8 malfunction events, in which the device had metal shavings.8 reported events had no patient involvement; no patient impact.

• Brand Name: WIRE COLLET (.7-1.8MM)
• Type of Device: ARTHROSCOPE
• 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: 6980769
• MDR Text Key: 91092244
• Report Number: 0001811755-2017-02085
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 8
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 4100062000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/02/2017
• Initial Date FDA Received: 10/26/2017
• Supplement Dates Manufacturer Received: 06/02/2017
• Supplement Dates FDA Received: 10/25/2018
• 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