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

Catalog Number 00880100100

Device Problems Failure to Cut (2587); Material Split, Cut or Torn (4008)

Patient Problem Abrasion (1689)

Event Date 03/18/2019

Event Type  Injury  

Manufacturer Narrative

This event is recorded by zimmer biomet under (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet.Once the product is returned and the investigation is complete, a follow up/final report will be submitted.

Event Description

It was reported that the device was not running smoothly using #2 guard as guard is rough.Device was erratically damaging patients skin and was unable to donate good skin for grafting.Event occurred during surgery.There was a delay of 16- 30 minutes and additional graft was required from the patient.An alternative device was used to complete the surgery.No additional patient consequences were reported as a result of this malfunction.

Event Description

No additional information received.

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 and previous repair record for zimmer air dermatome serial number (b)(4) was reviewed noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing.The record reviews found no issues with the device and all verifications, inspections, and tests were successfully completed.Using the machine-repair reports and the repair sites folders on livelink as well as sap to query for all repairs on serial number (b)(4) prior to 25 march 2019, the device was noted to have been previously repaired twice, the last repair being for the dermatome overheating reported on 10 november 2014.The reported event was confirmed by the service technicians who performed the evaluations and repair.On 25 march 2019, it was reported from waikato hospital that a dermatome was not running smoothly using the 2" width plate as the width plate was rough and that the dermatome would irratically damage the patient's skin.The customer returned a zimmer air dermatome serial number 110220 for evaluation.Evaluation of the device on 5 april 2019 by zimmer australia noted that the edge of the machine head was rough and that the depth bar had side and up/down play.All four of the width plates returned with the device were found to have been worn.The dermatome was forwarded to zimmer taiwan for further evaluation.Evaluation of the device by zimmer taiwan on 17 april 2019 found that the device was out of calibration at all four settings and that the motor ran at the low end of motor speed specifications.Upon further evaluation, it was found that the motor, multiple bearings, o-ring, seal, reciprocating arm, external e-ring, hinge throttle gasket, the phillip head screw seal, width plate screws, and all four width plates were defective.Repair of the device occurred on 22 april 2019 and involved replacing the motor, multiple bearings, o-ring, seal, reciprocating arm, external e-ring, hinge throttle gasket, the phillip head screw seal, width plate screws, and all four width plates.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 per zpo 5.3250.Reference number (b)(4) on 25 march 2019.While the service technicians found that the device was out of calibration at all four settings and that the control bar was found out of position, which would prevent the blade from sitting properly on the device and therefore allow the dermatome to not blade as intended and potentially damage the patient's skin during use, it cannot be determined from the information provided as to what occurred such that the dermatome fell out of calibration.In addition, while the technicians noted that the width plates were worn, which can lead to the dermatome not being able to move properly during use, it cannot be determined what caused the wear on the width plates.Therefore, a specific root cause of the reported events 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.

• Brand Name: ZIMMER AIR DERMATOME
• Type of Device: DERMATOME, PNEUMATICALLY-POWERED
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8482605
• MDR Text Key: 140902627
• Report Number: 0001526350-2019-00212
• 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: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• 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: 61396387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1