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

Catalog Number 00880100100

Device Problems Loose or Intermittent Connection (1371); Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 09/10/2019

Event Type  malfunction  

Manufacturer Narrative

This event is recorded by zimmer biomet under (b)(4).Udi# - (b)(4).The device history record and previous repair record for zimmer air dermatome serial number (b)(4) 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.On 13 september 2019, it was reported that bits and pieces came out of the dermatome handpiece during sterilization.The customer returned a zimmer air dermatome serial number (b)(4) for evaluation.Evaluation of the device by zimmer australia on 13 september 2019 noted that the device was returned with some of its components in a separate bag from the customer and that there was a loose bearing on the device.Upon further inspection, it was found that the surface of the dermatome was pitted and that the markings on the returned width plates had been worn off.The product was sent to zimmer (b)(4) for further evaluation and repair.Evaluation of the dermatome by zimmer (b)(4) on 2 october 2019 found that the device ran at the low end of motor speed specifications, and was out of calibration at all four settings.It was further mentioned that the motor, multiple bearings, o-ring, seal, reciprocating arm, external e-ring, machined head, and the four returned width plates were all defective.Repair of the dermatome occurred on 4 october 2019 and involved replacing the motor, multiple bearings, o-ring, seal, reciprocating arm, external e-ring, machined head, and the four returned width plates as well as recalibrating the device.The technician then tested and verified that the device was functioning as intended, then returned the dermatome to the customer without further incident.The device was tested, inspected, and repaired.While the customer returned the parts that had fallen out of the device and that there was a loose needle bearing on the device, indicating that the e-rings were the components that fell out, it cannot be determined from the information provided as to what caused the components to fall out of the device.As such, 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 for any adverse trends that may warrant further action.

Event Description

It was reported bits and pieces came out from the hand piece during sterilization, and small pieces of metal were noted to be loose.No adverse events were reported as a result of this malfunction.Investigation found that the handpiece worked slower/at a lower speed.

• 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: 9531350
• MDR Text Key: 197771064
• Report Number: 0001526350-2019-01206
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• 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: 63247421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2016
• 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