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

Catalog Number 00880100100

Device Problem Failure to Cut (2587)

Patient Problem No Code Available (3191)

Event Date 07/29/2019

Event Type  malfunction  

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.(b)(4).

Event Description

It was reported that the unit was not working well, the skin was taken irregularly it caused damage to the patient during the surgery.There was a delay of 30 minutes, and an alternate device was used to complete the procedure.No additional patient consequences were reported and no specific information was provided as to what the patient damage was.No additional information was available.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.The following sections were updated/corrected: b4, b5, d4, d10, g4, g7, h2, h3, h4, h6, h10.(b)(4).Reported issue: on (b)(6) 2019, it was reported that the unit was not working well, the skin was taken irregularly it caused damage to the patient during the surgery.The customer returned an air dermatome device, serial number (b)(6) for evaluation.The customer also returned a hose and 1 inch/2 inch/3 inch/4 inch width plates, for evaluation.Dhr review: the device history record (dhr) review noted no related non-conformances, requests for deviation, change notices or any other issues with manufacturing or with the device.The dhr review also found that all verifications, inspections and tests were successfully completed.Device evaluations results/investigation findings: product review of the air dermatome on august 13, 2019 revealed that the thickness adjustment lever was rough to turn to different settings.The calibration and motor speed were within specifications.Repair of the air dermatome was performed by zimmer biomet surgical on (b)(6) 2019 which included replacement of the die cast lever, ball plunger, semi-circle bearings, and vespel bearings.Air dermatome, serial number (b)(6) was then tested and functioned properly.It was repaired, inspected and tested.Probable cause/root cause: while the reported event of the unit not working well was confirmed during inspection of the device, a root cause for the reported issue cannot be determined with the information provided.The unit was functioning as intended after the die cast lever, ball plunger, semi-circle bearings, and vespel bearings were replaced.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Conclusion: review of the information provided during the investigation determined that there are no further actions needed at this time (ie/capa/scar/hhe/d).This complaint will be tracked and trended for any adverse trends that may warrant further action.

Event Description

No additional event information was received.

• 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: 8865637
• MDR Text Key: 153424647
• Report Number: 0001526350-2019-00612
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• 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: 63898251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other