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

Catalog Number 00880100100

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The device history record and previous repair record for zimmer skin graft mesher serial number (b)(4) were reviewed and 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 (b)(4) to query for all service on serial number(b)(4) prior to 22 april 2019, the device was noted to have been previously serviced three times, the last service being for annual maintenance reported on 7 november 2017.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.A corrective and preventative action (capa) implemented a serial number logbook to correct this issue.Using the machine-repair reports and the repair sites folders on (b)(4) to query for all repairs on serial number (b)(4) prior to 22 april 2019, the device was noted to have not been previously repaired.The device history record and previous repair record for zimmer air dermatome serial number (b)(4) were reviewed and 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.Review of the complaint history based on the above keywords found no other similar events related to the reported device; as such, no further additional action is required at this time.The reported event was confirmed by the service technician who evaluated and repaired the devices.On 22 april 2019, it was reported that a mesher, a meshgraft, and a dermatome were shredding skin.The customer returned a zimmer skin graft mesher serial number (b)(4), zimmer meshgraft ii serial number (b)(4), and zimmer air dermatome serial number (b)(4) for evaluation.Evaluation of the mesher on 23 may 2019 noted that the comb was bent on the device.None of the pretests could be performed due to the bent comb.Evaluation of the dermatome on the same day stated that the thickness control lever would move when it would be set to a specific thickness, but the device was within motor speed and calibration specifications.Evaluation of the meshgraft on 22 may 2019 found that the screws on the side plates were rusted and that the cutters and roller were worn.Repair of the meshgraft occurred on 22 may 2019 and involved replacing the roller, cutter, side plates, and screws as well as recalibrating the device.Repair of the dermatome and the mesher occurred the next day on 23 may 2019 and involved replacing the control bar, thickness control lever, and multiple bearings on the dermatome and the comb on the mesher as well as recalibrating both devices.All three devices were tested and verified to be functioning as intended and were returned to the customer without further incident.The mesher was tested, inspected, and repaired, the meshgraft was tested, inspected, and repaired, and the dermatome was tested, inspected, and repaired.Reference numbers (b)(4) on 22 april 2019 while the service technician found that the dermatome had a thickness control lever that would move after being set, which can allow the device to slip out of position during use and shred a potential graft, a mesher that had a bent comb that would interfere with any graft that would go through it and possible cut it incorrectly, or for a meshgraft with a defective cutter that would cause it to improper cut the graft, it cannot be determined from the information provided as to what caused these components to malfunction on the device.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.Review of the information provided during the investigation determined that there are no further actions needed at this time.This complaint will be tracked and trended per complaint trending procedure for any adverse trends that may warrant further action.

Event Description

It was reported that during investigation, it was found that the dermatome thickness control lever would move when it would be set to a specific thickness.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
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 8944245
• MDR Text Key: 159850289
• Report Number: 0001526350-2019-00724
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• 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: 61658780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1