MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO RADIOLUCENT RIGHT ANGLE DRIVE; ARTHROSCOPE

Catalog Number 4100355000

Device Problem Metal Shedding Debris (1804)

Patient Problem No Patient Involvement (2645)

Event Date 12/02/2016

Event Type  malfunction  

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program, exemption number (b)(64.One device was received for evaluation; the event was not confirmed during testing.There were metal shavings, however, no components were found to be out of specifications.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 shedding metal debris.There was patient involvement; swarfs remained in the patient, however no patient impact.

• Brand Name: RADIOLUCENT RIGHT ANGLE DRIVE
• 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: 6526062
• MDR Text Key: 74088053
• Report Number: 0001811755-2017-00919
• 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
• Report Date: 04/27/2017

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: 4100355000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/02/2016
• Initial Date FDA Received: 04/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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