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 03/02/2017

Event Type  malfunction  

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program, exemption number (b)(4).Seven devices were received for evaluation; 4 events were confirmed.Four devices were found to have bearing corrosion.Three devices were found to be within specifications for the reported event.Two devices are available for evaluation but have not yet been received.This device is not repairable and was not returned to the user facility.There were no remedial actions taken.This device is not labeled for single-use.

Event Description

This report summarizes 9 malfunction events in which the device had metal shedding debris.Two reported events had no patient involvement; no patient impact.Six reported events had patient involvement with no patient impact.One reported event had no known patient involvement or patient impact.

Manufacturer Narrative

(b)(4).1 device was received for evaluation; 1 event was not duplicated; however, the device was out of specifications.1 device was found to have corrosion.This device is not repairable and was not returned to the user facility.There were no remedial actions taken.This device is not labeled for single-use.Correction: one device was expected for evaluation; however, the device was not available.

Event Description

This report summarizes 9 malfunction events in which the device had metal shedding debris.2 reported events had no patient involvement; no patient impact.6 reported events had patient involvement with no patient impact.1 reported event had no known patient involvement or 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: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 6748072
• MDR Text Key: 81364553
• Report Number: 0001811755-2017-01460
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 9
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/11/2017

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: 03/02/2017
• Initial Date FDA Received: 07/27/2017
• Supplement Dates Manufacturer Received: 03/02/2017
• Supplement Dates FDA Received: 10/11/2017
• 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