MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. ZIMMER AIR DERMATOME; DERMATOME, PNEUMATICALLY-POWERED

Model Number N/A

Device Problems Failure to Cut (2587); Pressure Problem (3012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2021

Event Type  malfunction  

Manufacturer Narrative

This complaint is recorded by zimmer biomet under (b)(4).A follow up/ final report will be submitted once investigation is complete.

Event Description

It was reported that the device did not receive enough compressed air.For this reason the device was not working properly and skin grafts become ragged.There is no harm or delay reported.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Disregard h5 and a5 as they were previously reported on the initial mdr.Review of the most recent repair record determined the motor speed was unstable and the motor pin was damaged.The motor and pin were replaced and resolved the reported issue.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

There was no additional information.

• Brand Name: ZIMMER AIR DERMATOME
• Type of Device: DERMATOME, PNEUMATICALLY-POWERED
• 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: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13160558
• MDR Text Key: 283480143
• Report Number: 0001526350-2021-01338
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00880100100
• Device Lot Number: 63130445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2015
• 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