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 07/23/2018

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).It was reported that the device does not run stable (clarification showed that it¿s working on and off ¿ sometimes it works and sometimes not).Issue noticed during kit inspection - no patient involved and no harm to user.Summary: on (b)(6) 2018, it was reported that the device does not run stable (clarification showed that it¿s working on and off ¿ sometimes it works and sometimes not).The customer returned an air dermatome device, serial number (b)(4), for evaluation.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.Medicrea has not previously repaired/evaluated air dermatome serial number (b)(4) as documented in the repair reports in vdoc portal services.Product review of the air dermatome by medicrea on (b)(6) 2018 noted that the device calibration as out of specifications and the motor was used and corroded.It was stated that the thickness control shaft input test did not comply and the reciprocating arm was used.Repair of the air dermatome was not performed by medicrea on (b)(6) 2018 as the customer denied the repair quote and requested to return the device unrepaired.The reported event was confirmed since during the product review it was noted that the motor was used and corroded.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 motor was used and corroded.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.

Event Description

It was reported that the device does not run stable (clarification showed that it¿s working on and off ¿ sometimes it works and sometimes not).Issue noticed during kit inspection - no patient involved and no harm to user.No adverse events have been reported as a result of the malfunction.

• 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: 7824448
• MDR Text Key: 118534540
• Report Number: 0001526350-2018-00838
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: PEXEMPT
• 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: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 63171051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• Initial Date Manufacturer Received: 08/02/2018
• Initial Date FDA Received: 08/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2015
• 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