MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. ZIPPERED SURGICAL TOGA, 2XL; GOWN, SURGICAL

Model Number N/A

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/07/2020

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Once the investigation is completed, a follow-up/final report will be submitted.

Event Description

It was reported that the toga was bleeding through chest with minimal blood on outer toga.The event occurred during surgery.There was no harm and no delay.No adverse event has been reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.

Event Description

They were performing a strike though total hip arthroplasty, the surgeon was holding his hands across his chest while reviewing x-rays when the blood got through to his chest are.The incident happened during normal procedural techniques.

Manufacturer Narrative

This medwatch is being filed to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Device is used for treatment.A definitive root cause cannot be determined.The event cannot be confirmed.

Event Description

There is no additional information.

• Brand Name: ZIPPERED SURGICAL TOGA, 2XL
• Type of Device: GOWN, SURGICAL
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 10266909
• MDR Text Key: 199903550
• Report Number: 0001526350-2020-00595
• Device Sequence Number: 1
• Product Code: FYA
• Combination Product (y/n): N
• PMA/PMN Number: K132386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2021
• Device Model Number: N/A
• Device Catalogue Number: 00992041310
• Device Lot Number: 20819120004K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1