MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. UNKNOWN DERMATOME; DERMATOME, PNEUMATICALLY-POWERED

Model Number N/A

Device Problems Gas/Air Leak (2946); Material Deformation (2976); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/22/2020

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Once an investigation of the device is completed, a follow-up/final report will be submitted.(b)(6).

Event Description

It was reported that an unknown dermatome hose was working fine during the procedure until there was a loud pop and air started leaking from the hose.Nurses had to call for another dermatome to complete the surgery, which was received, attached and used with no problems and delays.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: b4, b5, g4, g7, h2, h3, h6 and h10.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Repair of the device was not performed because the device was not returned.Part and lot/serial identification are necessary for review of device history records, neither were provided.Device is used for treatment.Complaint history review cannot be performed without product identification.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The event cannot be confirmed.Device not returned.

Event Description

No additional event information.

• Brand Name: UNKNOWN DERMATOME
• Type of Device: DERMATOME, PNEUMATICALLY-POWERED
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 10033068
• MDR Text Key: 190391918
• Report Number: 0001526350-2020-00437
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1