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

Model Number N/A

Device Problem Output below Specifications (3004)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/18/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under cmp-(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 before surgery that the dermatome ran irregularly with small dropouts during the material check at the mayo stand.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded under zimmer biomet complaint number (b)(4).This report is being filed to relay additional information.The reported event was confirmed by the service technician who performed the evaluation and repair.On 7 january 2020, it was reported that a dermatome was not working and ran irregularly on (b)(6) 2019.The customer returned a zimmer air dermatome serial number (b)(6) for evaluation.Evaluation of the device on 27 january 2020 noted that the needle bearing was defective, the swivel was loose, and that the device was out of calibration at the zero setting.Upon further evaluation, it was found that the motor ran within motor speed specifications, but ran erratically.Repair of the dermatome occurred on 12 february 2020 and involved replacing the motor, needle bearing, swivel, motor sleeve and nut bearing lock.The technician then tested and verified that the device was functioning as intended, then returned the device to the customer without further incident.The device was tested, inspected, and repaired.While the service technician found that the motor ran erratically, which would cause the dermatome to not work as intended, it cannot be determined from the information provided as to what caused the motor to break down.As such, a specific root cause of the reported event cannot be determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Review of the information provided during the investigation determined that there are no further actions needed at this time.This complaint will be tracked and trended for any adverse trends that may warrant further action.

• 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: 9659927
• MDR Text Key: 178336025
• Report Number: 0001526350-2020-00123
• 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: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• 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: 60461127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1