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

Catalog Number 00880100100

Device Problem Failure to Cut (2587)

Patient Problem No Code Available (3191)

Event Date 10/18/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has been returned to the repair center for evaluation and investigation is in process.Once the investigation is completed, a supplemental report will be filed accordingly.

Event Description

It was reported that the product vibrates during use.The dermatome moves during the graft taken (setting knob does not hold enough) and the plate size 3 does not cut in the same way everywhere.Event occurred during surgery; it is unknown if there was patient harm but there was a delay of 30 minutes-1 hour reported while the patient was under anesthesia.No additional patient consequences have been reported.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.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.On (b)(6) 2019, it was reported that the product vibrates during use.The dermatome moves during the graft taken (setting knob does not hold enough) and the plate size 3 does not cut in the same way everywhere.The customer returned an air dermatome device, serial number (b)(4), for evaluation.Product review of the air dermatome by flextronics on (b)(6) 2019 revealed that the needle bearing was defective.The machined head was damaged and the swivel was loose.The calibration was out of specifications at all settings.The motor speed was within specifications and the control bar was not in the correct position.The customer hose and width plates were not returned for evaluation.Repair of the air dermatome was performed by flextronics on (b)(6) 2019 which included replacement of the vespel bearings, ball bearings, needle bearing, semi-circle bearings, machined head, and swivel.Air dermatome, serial number (b)(4), was then tested and functioned properly.It was repaired, inspected and tested.While the returned product investigation confirmed that the air dermatome had a defective needle bearing, it cannot be determined from the information provided what actually caused the reported event.Therefore, based on the information provided, a specific root cause of the reported event cannot be determined.The device was noted to be functioning as intended after the vespel bearings, ball bearings, needle bearing, semi-circle bearings, machined head, and swivel were replaced.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

Event Description

No additional event information.

• 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: 9273052
• MDR Text Key: 164887868
• Report Number: 0001526350-2019-00968
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00880100100
• Device Lot Number: 2417600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other