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

Catalog Number 4100125000

Device Problem Metal Shedding Debris (1804)

Patient Problem No Patient Involvement (2645)

Event Date 06/07/2016

Event Type  malfunction  

Event Description

It was reported that at the user facility the device was producing metal shavings.There was no report of the metal shavings entering the surgical site.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.

• Brand Name: PIN 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: 5756880
• MDR Text Key: 48400131
• Report Number: 0001811755-2016-00967
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 06/07/2016

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: Health Professional
• Device Catalogue Number: 4100125000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2016
• Initial Date FDA Received: 06/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2003
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1