MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO UNKNOWN_INSTRUMENTSTIRE_PRODUCT; APPARATUS, AUTOTRANSFUSION

Catalog Number UNK_IPR

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/08/2016

Event Type  Injury  

Event Description

It was reported the device was inserted during surgery and when the nurse attempted to remove the device the next day, only the drain tube came out not the drain tip.The physician assistant noticed that the drain was shorter and an x-ray was ordered.The drain was coiled behind the knee and patient was taken to surgery for removal.Attempts were made to obtain additional information about the event; no further information was received.

Manufacturer Narrative

The reported event was not duplicated and no failures were confirmed as the product for this investigation was not available for evaluation.Customer states product is not available.

Event Description

It was reported the device was inserted during surgery and when the nurse attempted to remove the device the next day, only the drain tube came out not the drain tip.The physician assistant noticed that the drain was shorter and an x-ray was ordered.The drain was coiled behind the knee and patient was taken to surgery for removal.Attempts were made to obtain additional information about the event; no further information was received.

• Brand Name: UNKNOWN_INSTRUMENTSTIRE_PRODUCT
• 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: 6150593
• MDR Text Key: 61595571
• Report Number: 0001811755-2016-02810
• Device Sequence Number: 1
• Product Code: CAC
• 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,Followup
• Report Date: 01/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_IPR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2017
• 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