MAUDE Adverse Event Report: ZIMMER SURGICAL TOTALSHIELD ZIPPERED SURGICAL TOGA, LARGE

Catalog Number 00990031110

Device Problems Device Reprocessing Problem (1091); Residue After Decontamination (2325)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/21/2015

Event Type  malfunction  

Event Description

It was reported that it was notified by a joint/recon representative of the staff that there were complaints of distorted field of vision due to oily film on the face shields of the total shield zippered surgical toga.Also, all the procedures were finished using the affected product.Additional information indicated that the reported issue was noted prior to use; however, the affected toga was taken onto the sterile field and used to complete the procedure.It was stated that there seems to be no pattern as to which part of the shield is affected by the film.The staff cannot tell if it is on the inside or outside surface of the shield; however, staff confirmed that they were unable to wipe away any of the reported residue.There was no pt or user harm reported.No additional clinical information was received at the time of this report.

Manufacturer Narrative

The device was returned to the manufacturer; however the investigation was not completed at the time of this report.A follow up medwatch will be submitted once the investigation is complete.

Manufacturer Narrative

Samples were sent to the analytical lab of the supplier for additional analysis and testing.Ten (10) samples from four (4) lots were analyzed and tested.Analysis of the samples concluded that adhesive used in the manufacturing process was observed on the faceshield of five (5) of the forty (40) samples.The defect was difficult to see with the naked eye; however it was visible under 20 times magnification.No "oily residue/film" was observed on the sample devices.Review of the manufacturing processes, review of the device history records (dhr) and incoming inspection records of affected lots, no applicable nonconformances were observed.Personnel familiar with the manufacturing process relative to the application of the observed adhesive on the product were interviewed.The adhesive is applied using a guide in the fixture to ensure a localized uniform application to the faceshield.Although it could not be confirmed, potentially misapplication of adhesive during assembling process could have resulted in the observed defect; however there is not sufficient evidence to determine the true impact of the process.Even though the cause of the complaint could not be determined, the personnel were trained based on the problem description.Since all manufactured lots reviewed passed release criteria, no further actions are required at this time.

• Brand Name: TOTALSHIELD ZIPPERED SURGICAL TOGA, LARGE
• Type of Device: TOTALSHIELD ZIPPERED SURGICAL TOGA, LARGE
• 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: 4791539
• MDR Text Key: 21066231
• Report Number: 1526350-2015-00094
• Device Sequence Number: 1
• Product Code: FYA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 08/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00990031110
• Device Lot Number: D141553
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/01/2015
• Date Manufacturer Received: 04/21/2015
• 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