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

Catalog Number 00880100100

Device Problem Noise, Audible (3273)

Patient Problem Sedation (2368)

Event Date 11/08/2019

Event Type  Injury  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Once the investigation is completed, a follow-up/final report will be submitted.(b)(6).

Event Description

It was reported that the device was noisy and performed at a sub-optimal level.Event occurred during surgery and while there was no harm reported, there was a delay of greater than 30 minutes with the patient under anesthesia.No other 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).This medwatch is being filed to relay additional information.The following sections were updated/corrected: b4, b5, d10, g4, g7, h2, h3, h6, h8, h10.The device history record and previous repair record for zimmer air dermatome serial number (b)(6) was reviewed and noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with the device.The record reviews found no issues with the device and all verifications, inspections, and tests were successfully completed.The reported event was confirmed by the service technician who performed the evaluation and repair.On (b)(6)2019 , it was reported that a dermatome was noisy and performed at a suboptimal level.The customer returned a zimmer air dermatome serial number (b)(6) for evaluation.Evaluation of the device by zimmer australia on (b)(6)2019 noted that the dermatome was running rough and erratically.The dermatome was forwarded to zimmer taiwan for further evaluation and repair.Evaluation of the dermatome by zimmer taiwan on (b)(6)2019 found that the device was out of calibration at all four settings and that the motor did not run.Upon further evaluation, it was found that there was a defective motor, multiple bearings, o-ring, seal, reciprocating arm, and external e-rings on the device.Repair of the dermatome occurred the same day and involved replacing the motor, multiple bearings, an o-ring, seal, reciprocating arm, and the external e-rings as well as recalibrating the device.The technician then tested and verified that the device was functioning as intended, then returned the device to the customer without further incident.While the service technician found that the device was out of calibration at all four settings, that the motor would not run, and that there were multiple defective components on the device, all of which would prevent the device from operating as intended, it cannot be determined from the information provided as to what caused all these issues with the product.In addition, the service technician does not confirm the reported noise issue with the device.As such, a specific root cause of the reported issues 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 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: 9344285
• MDR Text Key: 167127705
• Report Number: 0001526350-2019-01046
• 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: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• 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: 62689580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other