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

Model Number N/A

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 08/20/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during surgery the device was producing uneven grafts.There was direct impact to the patient; however, the direct impact is unknown as no further information was provided.No additional patient consequences have been reported as a result of this malfunction.

Manufacturer Narrative

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

Event Description

It was reported that during surgery the device was producing uneven grafts.There was no harm, no delay, no medical intervention, and no additional skin grafts needed.It was reported there were no adverse consequences that occurred as a result of this malfunction.

Event Description

No additional event information available.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined that the unit was out of calibration, and the control bar, machined head, and width plate were worn.The unit was recalibrated, and the machined head, control bar, and width plate were replaced and resolved the reported issue.Device is used for treatment.A definitive root cause cannot be determined.The event is confirmed.

• Brand Name: ZIMMER AIR DERMATOME
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 10548255
• MDR Text Key: 207543068
• Report Number: 0001526350-2020-00790
• 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: 12/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00880100100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other