MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO WIRE COLLET; ARTHROSCOPE

Catalog Number 4100062000

Device Problem Metal Shedding Debris (1804)

Patient Problem No Patient Involvement (2645)

Event Date 12/02/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Two devices were received for evaluation.The event was confirmed for one of the devices during testing.Evaluation found the collet component was worn.The event was not confirmed for the other received device.Evaluation found the device operated within specification and no failure was detected.These devices are not repairable and were not returned to the user facilities.One device was not received for evaluation.There were no remedial actions taken.These devices are not labeled for single-use.

Event Description

This report summarizes 4 malfunction events, in which there was metal shedding debris.There was patient involvement but no patient impact.

• Brand Name: WIRE COLLET
• 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: 5616096
• MDR Text Key: 44619015
• Report Number: 0001811755-2016-00424
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 4
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/02/2015

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
• Initial Date Manufacturer Received: 12/02/2015
• Initial Date FDA Received: 04/28/2016
• 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