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

Catalog Number 00880100100

Device Problem Loss of Power (1475)

Patient Problem No Patient Involvement (2645)

Event Date 04/08/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded under zimmer biomet complaint number (b)(4).The device has been returned for evaluation and investigation is in process.Once the investigation is completed, a supplemental report will be filed accordingly.

Event Description

It was reported that the device was stalls during use.The event occurred pre-surgery and there was no harm and no delay reported.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).Dhr review: the device history record (dhr) and previous repair report reviewed noted no related non-conformances, requests for deviation, change notices or any other issues with manufacturing or with the device.The dhr and previous repair report review also found that all verifications, inspections and tests were successfully completed.Device evaluations results/investigation findings: product review of the air dermatome on october 21, 2019 revealed that the device operated within motor speed specifications and was within calibration and side to side specifications at all tested thickness settings.It was noted that the device would run without the throttle being engaged as the poppet was stuck in the on position.The control bar was dinged towards the center and the blade area of the machined head was worn.Repair of the air dermatome has not yet been performed by zimmer biomet surgical as the aged repair quote has not yet been approved by the customer.Probable cause/root cause: the root cause of the reported event could not be specifically determined with the information that was provided.During the product review it was noted that the device operated within motor speed specifications.It was noted that the device would run without the throttle being engaged as the poppet was stuck in the on position.It was not noticed that the device would stall during operation.It is unknown with the information that was provided how this occurred.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 for any adverse trends that may warrant further action.

• 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: 8840569
• MDR Text Key: 152945132
• Report Number: 0001526350-2019-00596
• 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: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• 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: 60484769
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/25/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1