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 Known Impact Or Consequence To Patient (2692)

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).Three events were reported for this quarter.Two devices were received for evaluation; 2 events were confirmed during testing.Two devices were found to be affected by corrosion.One device was available for evaluation but has 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 3 malfunction events, in which the device was shedding metal debris.Two reported events had no patient involvement; no patient impact.One event had no known patient involvement; no known patient impact.

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program.Supplemental rationale: 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 not confirmed during testing; however, the device was found to be affected by nylon fibers.Additional information: this device is not labeled for single-use.This device was not reprocessed and reused.

Event Description

This report summarizes 3 malfunction events, in which the device was shedding metal debris.3 events had 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: 7219266
• MDR Text Key: 98520640
• Report Number: 0001811755-2018-00082
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 3
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/24/2018

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: 09/02/2017
• Initial Date FDA Received: 01/25/2018
• Supplement Dates Manufacturer Received: 09/02/2017
• Supplement Dates FDA Received: 10/24/2018
• 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