MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. SURGICAL HELMET; GOWN, SURGICAL

Model Number N/A

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/13/2018

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow up mdr will be submitted.

Event Description

It was reported that smoke was coming from the fan portion of the helmet.No adverse events were 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.The following sections were updated/corrected: date of event, udi#, pma/510k, if follow-up, what type, device evaluated by mfr, device manufacture date.(b)(4).Results: the device was not returned as the hospital indicated that it was thrown away.Hence, testing of the product could not be performed.The device history record (dhr) for the totalshield surgical helmet, part number: 00990000100 and lot number: 63646901, review noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing.The dhr review found no issues with the device and all verifications, inspections, and tests were successfully completed.On 16 apr 2018, it was reported from (b)(6) center that a totalshield surgical helmet had smoke coming from the fan portion of the helmet.A returned product investigation could not be performed for the reported event due to the product not being returned for evaluation.The reported event can, therefore, not be confirmed.The root cause of the reported event cannot be specifically determined with the provided information because the product was not returned for evaluation.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

Event Description

It was reported that during set up for a case, they noted that there was smoke was coming from the fan portion of the helmet.No delays and no harm reported.

• Brand Name: SURGICAL HELMET
• Type of Device: GOWN, SURGICAL
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 7504614
• MDR Text Key: 108264094
• Report Number: 0001526350-2018-00420
• Device Sequence Number: 1
• Product Code: FYA
• Combination Product (y/n): N
• PMA/PMN Number: PK132386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00990000100
• Device Lot Number: 63646901
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1