MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN_INSTRUMENTS_PRODUCT

Catalog Number UNK_INS

Device Problems Connection Problem (2900); Device Operates Differently Than Expected (2913)

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

Event Date 11/12/2014

Event Type  malfunction  

Event Description

The femoral nozzle is blocking when the cement is being pushed through the cartridge.The surgeon has said that the ¿piece of foam/plastic¿ between the join is not secure and that is why it is blocking the nozzle.You can actually see the piece on visual inspection of the affected nozzles.".

Manufacturer Narrative

Additional information has been requested and if received will be submitted in a follow up report upon completion of the investigation.Disposed of in the field.

Manufacturer Narrative

(b)(4).The reported event could not be duplicated as the product was not returned for investigation.The initially reported product number was incorrect and based upon the event description and provided lot number, no product identification could be made.Based on a review of general risk documentation from the stryker instruments division and the reported information regarding this event, it was determined that the event was not reportable as the event did not involve a product problem indicating a non-conformity, adverse trend or unanticipated hazard.No further action is required at this time.Product surveillance will continue to monitor complaints of this type for adverse trends.

Event Description

The femoral nozzle is blocking when the cement is being pushed through the cartridge.The surgeon has said that the piece of foam/plastic between the join is not secure and that is why it is blocking the nozzle.You can actually see the piece on visual inspection of the affected nozzles.".

• Brand Name: UNKNOWN_INSTRUMENTS_PRODUCT
• Type of Device: INSTRUMENT
• 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: rita intorrella ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4322522
• MDR Text Key: 5242883
• Report Number: 0002249697-2014-04605
• Device Sequence Number: 1
• Product Code: HTR
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_INS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/15/2015
• 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
• Patient Outcome(s): Other