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

Model Number N/A

Device Problems Patient Device Interaction Problem (4001); Activation Problem (4042)

Patient Problem Laceration(s) (1946)

Event Date 09/05/2023

Event Type  Injury  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).E1 telephone number: (b)(6).G2 foreign: france.Review of the most recent repair record determined the motor was seized.The motor and sleeve were replaced and resolved the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing.This device was manufactured in may 2014 and has not previously been returned for service.Per the ifu the zimmer air dermatome should be returned every 12 months for inspection and preventive maintenance.Annual factory calibration checks are strongly recommended to verify continued accuracy.A definitive root cause cannot be determined.The event is confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that during surgery the system did not oscillate.An additional skin graft was required.There was an unknown delay in the procedure, and the total surgical time was one hour and 30 minutes.Due diligence information complete.No additional information is available.

• Brand Name: ZIMMER AIR DERMATOME
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18640056
• MDR Text Key: 334538431
• Report Number: 0001526350-2024-00166
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• 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
• Device Lot Number: 62689594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Prefer Not To Disclose