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

Model Number N/A

Device Problem Incorrect Measurement (1383)

Patient Problems Laceration(s) (1946); No Consequences Or Impact To Patient (2199)

Event Date 01/17/2020

Event Type  Injury  

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 the device was not cutting properly; initially significantly thicker than expected for setting & for gauged thickness, then a significantly thinner graft was taken more proximally with reduced pressure.Consequently, the donor site was overgrafted in part.No other adverse events were reported as a result of this malfunction.

Event Description

Per follow up, the original graft was over-grafted.There was no harm or injury, the graft was thicker than expected.There was not a significant delay in surgery.No adverse event.

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, h1, h2, h3, h6, h8, h10.-it cannot be determined if the air dermatome serial number n/a has not been previously repaired/evaluated before (b)(6)2020 due to the serial number being unknown.-a product review of the air dermatome serial number n/a cannot be conducted due to the product being discarded by the customer.-repair of the device was not performed because the product was not returned.-lot/serial identification is necessary for review of device history records, and lot and serial identification were not provided.-device is used for treatment.Review of complaint history identified additional similar complaints for the reported item.Complaints are monitored through monthly complaint review (reference (b)(4) and (b)(4)) 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 cannot be confirmed.H3 other text : product discarded.

• 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: 9746205
• MDR Text Key: 181981942
• Report Number: 0001526350-2020-00210
• 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: 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 00880200300ZIMMER DERMATOME 3" WIDTH PLATE
• Patient Outcome(s): Other