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

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source - foreign - (b)(6).The investigation is still in progress.Once the investigation is complete a follow up mdr will be submitted.

Event Description

It was reported that an unknown repair occurred for an unknown reason.An unknown serious injury occurred with the device.Additional follow up is being conducted for more information.If/once additional information is received then a follow up report will be filed.No additional consequences were reported.

Manufacturer Narrative

Upon receipt of additional information, it has been determined that this device did not cause or contribute serious injury.The initial report was forwarded in error and should be voided.

Event Description

Additional information has indicated that this device did not cause or contribute serious injury.

• 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: 11377606
• MDR Text Key: 233447147
• Report Number: 0001526350-2021-00203
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• 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: 07/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other