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

Catalog Number 00880100100

Device Problems Inadequacy of Device Shape and/or Size (1583); Failure to Cut (2587)

Patient Problem No Patient Involvement (2645)

Event Date 02/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Once the investigation is completed, a follow up/final report will be submitted.

Event Description

Take thinner than setting.The event occurred during testing.There was no harm or delay involved.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).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 and the medicrea database to query for all repairs on serial number (b)(4) prior to 8 february 2019, the device was noted to have been previously repaired once for it not cutting properly reported on (b)(6) 2018.The reported event was confirmed by the service technician who performed the evaluation and repair.On (b)(6) 2019, it was reported from karolinska universitetssjukhuset that a dermatome was taking a thinner graft that what it was set to.The customer returned a zimmer air dermatome, serial number (b)(4), for evaluation.Evaluation of the device on (b)(6) 2019 noted that the dermatome was out of side to side calibration at the zero setting and that the control bar was not in the proper position.Repair of the dermatome occurred on (b)(6) 2019 and involved replacing the sleeve and shaft bearings as well as recalibrating the device.The technician then verified that the device was functioning as intended and the dermatome was returned to the customer without further incident.The device was tested, inspected, and repaired.While the service technician found that the device was out of calibration and control bar was not in the correct position, which would allow the blade to not be placed correctly on the device and cause the blade to not take a proper cut during use, it cannot be determined from the information provided how the control blade was moved.Therefore, a specific root cause of the reported event 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: ZMR AIR DERMATOME HANDPIECE
• Type of Device: DERMATOME, PNEUMATICALLY-POWERED
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8358835
• MDR Text Key: 136786472
• Report Number: 0001526350-2019-00125
• 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: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• 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: 60266839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1