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

Catalog Number 4100062000

Device Problems Overheating of Device (1437); Metal Shedding Debris (1804)

Patient Problem No Patient Involvement (2645)

Event Date 09/01/2016

Event Type  malfunction  

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program, (b)(4).One device is available for evaluation but has not yet been evaluated.There were no remedial actions taken.This device is not labeled for single-use.

Event Description

This report summarizes 1 malfunction event, in which the device was reportedly overheating and had metal shavings coming from it.There was no patient involvement; no patient impact.

Manufacturer Narrative

(b)(4).1 device was received for evaluation.The event was confirmed for metal shedding debris.Though the overheating was not duplicated; the device was found to be outside specifications for the reported event.The device was found to have debris, corrosion, and shattered bearings.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 1 malfunction event, in which the device was reportedly overheating and had metal shavings coming from it.There was 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: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 6280088
• MDR Text Key: 66038118
• Report Number: 0001811755-2017-00271
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/31/2017

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: 09/01/2016
• Initial Date FDA Received: 01/26/2017
• Supplement Dates Manufacturer Received: 09/01/2016
• Supplement Dates FDA Received: 07/31/2017
• 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