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

Model Number N/A

Device Problems Energy Output Problem (1431); Loss of Power (1475); Device Stops Intermittently (1599)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/14/2016

Event Type  malfunction  

Manufacturer Narrative

The device was returned to the manufacturer; however the investigation was not completed at the time of this report.Initial qa inspection of the electric dermatome on january 4, 2017 revealed that the device would not run, and the calibration was out of specification at 30 setting.It was also noted that the control bar was flush with the master blade repair of the electric dermatome was performed by zimmer biomet surgical on (b)(6) 2017 which included replacement of the power cord assembly, power switch, thickness lever, reciprocating arm, bearings, seal and retaining ring, calibration shaft, motor, and o-ring.The electric dermatome was then tested and functioned properly.It was repaired, inspected and tested.A follow up medwatch will be submitted once the investigation is complete.Received; however, not yet evaluated.

Event Description

It was initially reported the device had very little power in the beginning, then it was working intermittently during surgery.On january 9, 2017 additional information was received confirming there was no harm or injury to the patient or operator.The surgery was delayed about three minutes at the most due to it taking a little longer to harvest.However, the harvested graft was useable and no additional grafts were required.

Manufacturer Narrative

Initial qa inspection of the electric dermatome power supply sn (b)(4) on january 5, 2017 revealed that the unit functioned as intended and passed all required testing.There was no repair needed as the device functioned as intended and met all required specifications.The electric dermatome power supply was inspected and tested.A follow up medwatch will be submitted once the investigation is complete and a root cause has been established.

Manufacturer Narrative

This complaint is being reported by zimmer biomet as (b)(4).The customer returned an electric dermatome device for evaluation.The customer also returned a power supply, 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.Zimmer biomet surgical has not previously repaired/evaluated the electric dermatome.Zimmer biomet surgical has not previously repaired/evaluated the electric dermatome power supply.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.The reported event was confirmed since during the initial inspection it was noted that the device would not run.While during the initial inspection it was noted that the device would not run, it is unknown with the information that was provided how this occurred.Therefore, based on the information that was provided the root cause of the reported event could not be specifically determined.The electric dermatome was repaired, tested and returned to the customer.

• Brand Name: HANDPIECE, ELECTRIC 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: 6264749
• MDR Text Key: 65666208
• Report Number: 0001526350-2017-00032
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2017
• 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: 00882100100
• Device Lot Number: 61880989
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2011
• 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