MAUDE Adverse Event Report: ZIMMER SURGICAL DISPOSABLE MIXING BOWLS WITH SPATULA

Catalog Number 00-5049-011-00

Device Problems Contamination (1120); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2015

Event Type  malfunction  

Event Description

It was reported that a foreign material got mixed within the packaging of the spatula.Additional info obtained indicated that the reported contaminated product entered the sterile field.The customer used and finished the surgery with an alternative one.There was no patient harm or delays reported.

Manufacturer Narrative

The device was not returned to the mfr at the time of this report.A f/u medwatch will be submitted, once the device has been returned and the investigation is complete.

Manufacturer Narrative

The device was returned on 05/20/2015 in a plastic zip lock bag.The spatula and pouch and the mixing bowl were returned.The contamination was captured and saved on two sticky tabs and was inside the spatula pouch.No obvious damage was visible with the returned product.The evaluation of the contamination that was returned with the device appears to be plastic - most probably flashing from the spatula.This evaluation was accomplished using a digital electronic microscope.The customers reported event was foreign material was found inside the pouch of the spatula.The information provided and the returned product confirm that contaminant was found by the customer.The review of the device history record (dhr) noted no non-conformances.Requests for deviation (rpd's) or other issues.The quality records show that this lot was prepared in accordance with the requirements of the quality management system and all the quality control tests were passed successfully.Additionally, the review of the manufacturing process noted no systemic issues.The particulate is larger than the allowable size according to the procedure.The most likely cause for this contamination is flashing on the spatula was sloughed off and captured in the sealed pouch during handling and transit after packaging.

• Brand Name: DISPOSABLE MIXING BOWLS WITH SPATULA
• Type of Device: DISPOSABLE MIXING BOWLS WITH SPATULA
• Manufacturer (Section D): ZIMMER SURGICAL; 200 west ohio ave.; dover OH 44622
• Manufacturer Contact: kathleen smith ; 200 west ohio ave.; dover, OH 44622 ; 3303438801
• MDR Report Key: 4751470
• MDR Text Key: 5891174
• Report Number: 1526350-2015-00085
• Device Sequence Number: 1
• Product Code: GAF
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,company representative
• Reporter Occupation: Unknown
• Type of Report: Initial,Followup
• Report Date: 04/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2017
• Device Catalogue Number: 00-5049-011-00
• Device Lot Number: 62735851
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/20/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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