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

Model Number N/A

Device Problem Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2017

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under cmp-(b)(4).On (b)(6) 2017, it was reported that the product lacks power and stops.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 (rfd), change notices (cn) or any other issues with manufacturing.The dhr review found no issues with the device and 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 (b)(4).Initial qa inspection of the air dermatome by medicrea on february 2, 2017 revealed that the motor and swivel are completely corroded and worn.It was also revealed that the eccentric shaft, the thickness control shaft, the control bar were twisted and the head is damaged especially on the cutting space.Repair of the air dermatome was not performed by medicrea on april 27, 2017 customer denied the repair quotation and requested to destroy the device on april 28, 2017.The reported event was confirmed since during initial inspection it was revealed that the motor and swivel are completely corroded and worn.However, it was also revealed that the eccentric shaft, the thickness control shaft, the control bar were twisted and the head is damaged especially on the cutting space.The root cause of the reported event was due to the motor which is completely worn and corroded.However, it was also revealed that the eccentric shaft, the thickness control shaft, the control bar were twisted and the head is damaged especially on the cutting space.The device was not repaired as the customer denied the repair quotation.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 product was lacking power and stopping during surgery.There was a short delay of 5-15 minutes.No adverse events were reported as a result of this 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: 7070219
• MDR Text Key: 94204876
• Report Number: 0001526350-2017-00911
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 11/29/2017

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 Model Number: N/A
• Device Catalogue Number: 00880100100
• Device Lot Number: 32453000
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/28/2017
• Initial Date FDA Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2000
• 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