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

Catalog Number 00880100100

Device Problem Loss of Power (1475)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that product is in the process of being returned to zimmer biomet for investigation.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

It was reported that an air dermatome stopped working part way through graft.No adverse events were reported as a result of this malfunction.

Event Description

No additional event information available.

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 was unable to be performed as the dhr associated with this device is not available.This device was manufactured prior to may 2009 where it was identified a robust dhr indexing and handling process was not in place.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 11 february 2019, the device was noted to have been previously repaired once for times, the last repair being for the dermatome not taking skin reported on 4 may 2016.The reported event was confirmed by the service technician who performed the evaluation and repair.On 11 february 2019, it was reported from zimmer canada that a dermatome had stopped working part way through a graft.The customer returned a zimmer air dermatome, serial number (b)(4), for evaluation.Evaluation of the device on 18 march 2019 found that the calibration was out of side to side specifications at the zero setting and that the motor was within motor speed specifications, but ran erratically.The head and control bar had visible damage.Repair of the dermatome occurred the same day and involved replacing the head, control bar, motor, swivel, poppet assembly, calibration shaft, eccentric shaft, and multiple bearings.The technician then tested and verified that the device was functioning as intended, and the dermatome was returned to the customer without further incident.The dermatome was tested, inspected, and repaired.Reference number (b)(4) on 11 february 2019.While the service technician found that the motor was running erratically, which can cause the device to not generate the correct power to move the reciprocating arm and therefore not cut a graft as intended, it cannot be determined from the information provided as to what lead to the motor failing.Therefore, a specific root cause of the reported.

Manufacturer Narrative

This follow up report is being submitted to report additional information.

Event Description

New information received : there was a 10 minute delay to prepare another device.No adverse events were reported as a result of this malfunction.

• 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: 8396308
• MDR Text Key: 138413853
• Report Number: 0001526350-2019-00151
• 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,Followup
• Report Date: 04/04/2019

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: Health Professional
• Device Catalogue Number: 00880100100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/11/2019
• Initial Date FDA Received: 03/06/2019
• Supplement Dates Manufacturer Received: 03/12/2019; 04/03/2019
• Supplement Dates FDA Received: 03/13/2019; 04/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1