MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. ZIMMER AIR DERMATOME, COMPLETE

Catalog Number 00880100000

Device Problem Gas/Air Leak (2946)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that an air dermatome was leaking air between the handset and hose.No adverse events were reported as result of this malfunction.

Event Description

No additional event information is available.

Manufacturer Narrative

This event has been recorded under zimmer biomet complaint number (b)(6).Product review of the air dermatome serial number (b)(6) by flextronics on (b)(6) 2020 revealed that the needle bearing was worn, the swivel was missing a pin, the hinge was missing, the unit was out of calibration and the control bar position was incorrect.Repair of the device was performed by flextronics on (b)(6) 2020 which included replacement of the hinge, needle bearing, and swivel.The device, serial number (b)(6), was then tested and functioned properly.It was repaired, inspected and tested.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Device is used for treatment.Review of complaint history identified additional similar complaints for the reported item and no additional complaints for the reported part and lot combination.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The event is confirmed.

Event Description

It was reported that an air dermatome was leaking air between the handset and hose.The fault was discovered during set-up before the operation had started.Because this is a large burns unit / trauma centre, they have many of these devices on the shelf in sterile stores, so simply opened another one and used that when the patient was brought to theatre.It was reported that there was no delay to the surgical procedure, nor was there any harm/injury to the patient or operator.No adverse events were reported as 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.

• Brand Name: ZIMMER AIR DERMATOME, COMPLETE
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 9758341
• MDR Text Key: 195002199
• Report Number: 0001526350-2020-00221
• 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,Followup
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00880100000
• Device Lot Number: 62697471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1