MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. HIGH CAPACITY INTRAMEDULLARY BRUSH TIP; LAVAGE, JET

Model Number N/A

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/19/2017

Event Type  Injury  

Manufacturer Narrative

The complaint is being reported by zimmer biomet as (b)(4).Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during surgery the tip of the femoral brush attachment of the device was broken off and was found in the patient's wound prior to closure.No additional patient consequences were reported.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.The following sections were updated/corrected: investigation summary: review of the device history record could not be performed as the lot number was misreported for this complaint.Product examination could not be performed as no product was returned for this complaint.However, a photo provided by the customer shows that the nozzle piece of the tip has broken off.This complaint is confirmed.The root cause of the reported event could not be specifically determined with the provided information.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

Event Description

Per investigation, a photo provided by the customer shows that the nozzle piece of the tip was broken off.

• Brand Name: HIGH CAPACITY INTRAMEDULLARY BRUSH TIP
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6700131
• MDR Text Key: 79570326
• Report Number: 0001526350-2017-00407
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00515018300
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2017
• 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: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other