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

Catalog Number 00880100100

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 08/23/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Udi: (b)(4).Foreign: (b)(6).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 by zimmer biomet 13 september 2019 revealed that the reported event could not be replicated.It was noted that some screws were missing, the need bearing was damaged, the unit was out of calibration, and the control bar position was not correct.Repair of the air dermatome was performed by zimmer biomet surgical which included replacement of the needle bearing and screws.Air dermatome, serial number (b)(4), was then tested and functioned properly.It was repaired, inspected and tested.Probable cause/root cause: the reported event was never confirmed during inspection of the device.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 (ie/capa/scar/hhe/d).This complaint will be tracked and trended, for any adverse trends that may warrant further action.

Event Description

It was reported that the device did not power on after it came into contact with water.The device was machine washed.This took place outside of surgery and there was no harm involved.The investigation stated that some screws were missing, the need bearing was damaged, the unit was out of calibration, and the control bar position was not correct.No adverse events were reported as a result of this malfunction.

• Brand Name: ZMR AIR DERMATOME HANDPIECE
• 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: 9357271
• MDR Text Key: 189625249
• Report Number: 0001526350-2019-01060
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• 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: 63392275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1