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

Model Number N/A

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Physical Resistance/Sticking (4012)

Patient Problem Abrasion (1689)

Event Type  Injury  

Manufacturer Narrative

This event is recorded by zimmer biomet under (b)(4).Phone number: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet.Once the product is returned and the investigation is complete, a follow up/final report will be submitted.

Event Description

It was reported that the hand piece was sticking and took a thick layer of skin and tissue.This had to be sutured back on the patient.Another dermatome was used to finish the procedure.No additional patient consequences were reported.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The investigation is complete.Review of the most recent repair record determined the needle bearing was corroded and had seized and was replaced and resolved the reported issue.It was noted that the device has not been regularly returned for annual pm.The zimmer air dermatome should be returned every 12 months for inspection and preventative maintenance.Annual factory calibration checks are strongly recommended to verify continued accuracy.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Device is used for treatment.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.

Event Description

No additional information 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: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12751670
• MDR Text Key: 280120034
• Report Number: 0001526350-2021-01232
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• 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
• Device Lot Number: 62374702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2013
• 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): Other