MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO CBCII W/QUICK DISCONNECT, 3/16 INCH ROUND PVC DRAIN & TROCAR"; APPARATUS, AUTOTRANSFUSION

Catalog Number 0225028926

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/11/2017

Event Type  Injury  

Manufacturer Narrative

Customer doesn't have the product to return.

Event Description

The user facility reported that the patient returned to surgeon's office for routine post-op visit.A routine x-ray showed tip of drain lodged behind the patella.A surgery was required to remove the drain.The drain was removed through the arthroscopy portal, and there were no complications noted.

• Brand Name: CBCII W/QUICK DISCONNECT, 3/16 INCH ROUND PVC DRAIN & TROCAR"
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615
• Manufacturer (Section G): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 7012588
• MDR Text Key: 91414535
• Report Number: 0001811755-2017-02338
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 4546540867551
• UDI-Public: (01)4546540867551
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970714
• 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: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0225028926
• Device Lot Number: 17130012
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other