MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. ZIMMER ELECTRIC DERMATOME HP

Catalog Number 00882100100

Device Problems Failure to Cut (2587); Output Problem (3005)

Patient Problem Abrasion (1689)

Event Date 04/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Once the product is returned and the investigation is complete, a follow up/final report will be submitted.(b)(4).

Event Description

Device took too thick skin graft despite in which level the thickness knob is.This was noticed after 5 centimeter of the graft was taken.The thickness knob was set at the regular 0,25mm.The graft was carefully removed after the device was turned off.Another skin graft was attempted to be taken at 0,05mm but the device did not work anymore.Device also stopped working during operation.The event took place during surgery and there was an additional skin graft required from the patient.There was a delay of 30 minutes, but an alternate device was used to complete the procedure.No additional patient consequences were 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) and previous repair report reviewed noted no related non-conformances, requests for deviation, change notices or any other issues with manufacturing or with the device.The dhr and previous repair report review also found that all verifications, inspections and tests were successfully completed.Mecidrea/zimmer biomet surgical has previously repaired/evaluated electric dermatome serial number (b)(4) five times as documented in the repair reports in livelink.The last repair was december 17, 2015 where it was reported that the device was not working properly and the bearings, spring seal, needle bearing, semi-circle bearings, vespel bearings, seal/strain relief, plug harness assembly, screws, external e-ring, and fine adjustment cams were replaced.This is not a related issue.On april 25, 2019, it was reported that the device took too thick skin graft despite in which level the ''thickness knob'' is.This was noticed after 5 centimeter of the graft was taken.The thickness knob was set at the regular 0,25mm.The graft was carefully removed after the device was turned off.Another skin graft was attempted to be taken at 0,05mm but the device did not work anymore.Device also stopped working during operation.The customer returned an electric dermatome device, serial number (b)(4) for evaluation.Product review of the electric dermatome by flextronics on may 28, 2019 revealed that the machined head was damaged and the needle bearing was defective.The calibration was out of specifications at all settings and the control bar was not in the correct position.The motor did not run.The customer did not return a power supply for evaluation.Repair of the electric dermatome was not performed as the customer requested that the device be returned to them unrepaired.It was inspected and tested.Although the reported event was confirmed during inspection of the device, it cannot be determined from the information provided what caused the reported event and the device was returned to the customer without repair.Therefore, the root cause could not be determined.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 adverse events were reported as a result of this malfunction.

• Brand Name: ZIMMER ELECTRIC DERMATOME HP
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8623939
• MDR Text Key: 145508191
• Report Number: 0001526350-2019-00379
• 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,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00882100100
• Device Lot Number: 61153249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other