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

Catalog Number 00880100100

Device Problem Expulsion (2933)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Customer indicated that the product would be returned to zimmer biomet for investigation, however further follow up attempts went unanswered.Once the investigation has been completed, a follow up mdr will be submitted.

Event Description

It was reported that the hose "exploded" during surgery.Customer was unsure whether the issue is with the handpiece or the nitrogen.There was no harm and no delay.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).D4: udi - (b)(4).Reported issue: on july (b)(6) 2019, it was reported that e hose was exploded during surgery.Customer was unsure whether the issue is with the hand piece or the nitrogen.The customer returned an air dermatome device, serial number (b)(6), 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.Zimmer biomet surgical has not previously repaired/evaluated air dermatome serial number (b)(6) as documented in the repair reports in livelink.Device evaluations results/investigation findings: product review of the air dermatome on (b)(6) 2019 revealed the calibration and motor speed were both within specifications.The control bar was in the correct position.The thickness lever was replaced due to it being rough.The customer hose and width plates were not returned for evaluation.Repair of the air dermatome was performed by zimmer biomet surgical on (b)(6) 2019 which included replacement of the semi-circle shaft bearings, vespel bearings, die cast lever, ball plunger, and a new hose was sent to the customer.Air dermatome, serial number (b)(6), was then tested and functioned properly.It was repaired, inspected and tested.Probable cause/root cause: although the reported event was confirmed during inspection of the device, it cannot be determined from the information provided what caused the hose to fail.Therefore, the root cause could not be determined.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.This complaint will be tracked and trended per for any adverse trends that may warrant further action.

Event Description

No additional event information.

• 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: 8871120
• MDR Text Key: 153888083
• Report Number: 0001526350-2019-00635
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2019
• 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: 64276928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1