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

Catalog Number 4100062000

Device Problems Leak/Splash (1354); Metal Shedding Debris (1804)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/04/2015

Event Type  malfunction  

Manufacturer Narrative

Information is not yet available regarding adverse consequences, surgical delay, and if the surgery was completed successfully.Attempts are being made to retrieve this information from the customer.

Event Description

It was reported that during a procedure at the user facility the device was spitting water, rust, and small particles when initially used.The would had to be irrigated.

Manufacturer Narrative

Product not being returned to stryker instruments for evaluation per customer.Customer sent item to get repaired at a different company and now says the device is working fine.The reported event was not duplicated and no failures were confirmed as the product for this investigation was not available for evaluation.Customer is no longer sending product in to stryker for repair.

Event Description

It was reported that during a procedure at the user facility the device was spitting water, rust, and small particles when initially used.The would had to be irrigated.

• 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: 5334575
• MDR Text Key: 34669914
• Report Number: 0001811755-2015-04813
• 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,Followup
• Report Date: 12/01/2015

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: Health Professional
• Device Catalogue Number: 4100062000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/01/2015
• Initial Date FDA Received: 12/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/17/2016
• 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