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

Catalog Number 00880100100

Device Problems Loss of Power (1475); Gas/Air Leak (2946)

Patient Problem Abrasion (1689)

Event Date 11/13/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has been returned for evaluation and investigation is in process.Once the investigation is completed, a supplemental medwatch will be filed accordingly.

Event Description

It was reported that the device was not connecting properly and leaking air.Mid-harvest, the dermatome went silent and completely stopped functioning, despite the action being activated.The compressed nitrogen source and hose were checked and were fine, leading us to the conclusion that the stoppage was within the mechanism of the dermatome itself.Harvested further skin with a second dermatome.As a result, the patient's wound was closed with two pieces of skin graft with a seam, as opposed to a single, seamless skin graft.Another device was used to complete the surgery.A delay of 10 minutes was reported.No additional consequences were reported.

Manufacturer Narrative

(b)(4).This medwatch is being filed to relay additional information.On (b)(6) 2018, it was reported that the device was not connecting properly and leaking air.Mid-harvest, the dermatome went silent and completely stopped functioning, despite the action being activated.The compressed nitrogen source and hose were checked and were fine, leading us to the conclusion that the stoppage was within the mechanism of the dermatome itself.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.Zimmer biomet surgical has not previously repaired/evaluated air dermatome serial number (b)(4) as documented in the repair reports in livelink.Product review of the air dermatome on december 6, 2018 revealed that the calibration was out of specifications at all settings.The motor speed was within specifications but ran erratically.The head and control bar were visibly damaged.The customer hose and width plates were not returned for evaluation.Repair of the air dermatome was performed by zimmer biomet surgical on december 6, 2018 which included replacement of the ball detent, thickness lever, reciprocating arm, bearings, seal and retaining ring, motor, poppet assembly, damaged head, damaged control bar, calibration shaft, and swivel.Air dermatome, serial number (b)(4), was then tested and functioned properly.It was repaired, inspected and tested.The reported event was non-verifiable since during the product review it was noted that the device operated within motor speed specifications but was erratic.The head and control bar were visibly damaged and the device was outside calibration specifications at all tested thickness settings.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 device operated within motor speed specifications but was erratic.The head and control bar were visibly damaged and the device was outside calibration specifications at all tested thickness settings.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

No additional event information available.

• 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: 8137510
• MDR Text Key: 129467076
• Report Number: 0001526350-2018-01080
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 61480980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/20/2018
• Initial Date FDA Received: 12/06/2018
• Supplement Dates Manufacturer Received: 01/24/2019
• Supplement Dates FDA Received: 01/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention