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

Catalog Number 4100062000

Device Problem Metal Shedding Debris (1804)

Patient Problem No Information (3190)

Event Date 01/07/2015

Event Type  malfunction  

Event Description

It was reported that metal shavings were observed to come out of the wire collet.No patient or user injuries or adverse consequences were reported.The user facility was unable to provide additional information regarding the event.

Manufacturer Narrative

Device eval: customer discarded.

• 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: 4485746
• MDR Text Key: 5501135
• Report Number: 0001811755-2015-00374
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/07/2015

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: Other
• Device Catalogue Number: 4100062000
• Device Lot Number: 08275
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/07/2015
• Initial Date FDA Received: 02/04/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/18/2006
• 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