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

Catalog Number 00880100100

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 09/04/2019

Event Type  malfunction  

Manufacturer Narrative

This event is recorded by zimmer biomet under (b)(4).Once the investigation is complete, a follow up/final report will be submitted.

Event Description

It was reported that the device was striping the graft.There was no harm and no delay reported.Customer did not have any further information available.No adverse events were reported as a result of this malfunction.

Event Description

No additional event information is available.

Manufacturer Narrative

This event has been recorded under zimmer biomet complaint number (b)(4).This report is being filed to relay additional information.Udi#: (b)(4).The customer returned air dermatome, serial number (b)(4), and the hose for evaluation.Product review of the air dermatome by zimmer biomet surgical on 17 sept 2019 revealed that the calibration was out of specification at the zero setting only.The motor speed was in specification.Repair of the air dermatome was performed by zimmer biomet surgical on 17 sept 2019 which included replacement of the vespel and semi-circle bearings and recalibration of the device.Air dermatome, serial number ((b)(4)), was then tested and functioned properly.It was repaired, inspected and tested.The root cause of the reported event cannot be specifically determined with the provided information because reported event was unable to be reproduced.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

• 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: 9078481
• MDR Text Key: 158971935
• Report Number: 0001526350-2019-00784
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00880100100
• Device Lot Number: 63817611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1