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

Catalog Number 00880100100

Device Problem Loss of Power (1475)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).It reported that initially the complaint was found that it was preventive maintenance.Later it was noticed that the unit required repair.The device history record (dhr) review noted no related non-conformances, requests for deviation, change notices or any other issues with manufacturing or with the device.The dhr review also found that all verifications, inspections and tests were successfully completed.Zimmer biomet surgical has previously repaired/evaluated air dermatome serial number (sn) (b)(4) as documented in the repair reports.The last repair was on (b)(6) 2017.On (b)(6) 2018 it was reported that initially the complaint was found that it was preventive maintenance.Later it was noticed that the unit required repair.The initial inspection showed that the motor rpms were below specifications and the bearings were rough.The three inch width plate would not slide into position.The recalibration was out at zero setting only.The motor, bearings, thickness lever and three inch width plate were replaced on the device.The device was tested and calibrated to specifications.While this device was brought in for preventative maintenance, it was noted that it required repair for additional defective components.It is unknown with the information that was provided what led to the defectiveness of the replaced components.Therefore, based on the information that was provided the root cause of the reported event could not be specifically determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Based on the information provided, this investigation determined that there is no need for further action at this time.This complaint will be tracked and trended for any adverse trends that may require additional actions.

Event Description

It was reported that the device was sent in for preventive maintenance.Upon the initial inspection it was found that the motor rpms were below specifications which could cause inconsistent speed.There was no patient involvement or report of harm or delay as a result of this incident.

• 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: 9261696
• MDR Text Key: 189592213
• Report Number: 0001526350-2019-00952
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 00880100100
• Device Lot Number: 63278416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/04/2018
• Initial Date FDA Received: 10/31/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2016
• 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