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

Model Number N/A

Device Problem Loss of Power (1475)

Patient Problem Abrasion (1689)

Event Type  Injury  

Manufacturer Narrative

This event is recorded with zimmer biomet under (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that one of three electric dermatome hand piece shut down while taking skin graft.Multiple electric dermatome boxes and hand pieces were tried and units were plugged into different outlets.Air dermatome was used after all electric hand pieces did not work.The surgeon did not consider harm reaching the patient, but another graft had to be taken with the air handpience.There was no harm reached the patient and hand piece was switched to air before taking the graft.There was a delay of 20 minutes.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Udi: (b)(4).Power supply, elec.Dermatome/ pn 00882100600/ sn (b)(4).The device history record for zimmer electric dermatome serial number (b)(4) was reviewed noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing.The record reviews found no issues with the device and all verifications, inspections, and tests were successfully completed.On 13 february 2019, it was reported from (b)(6) medical center that a dermatome shut down while taking a graft.Prior to taking the graft, the dermatome was also tested and was not turning on properly.The customer returned a zimmer electric dermatome, serial number (b)(4), and a zimmer electric dermatomer power supply, serial number (b)(4), for evaluation.Evaluations of the dermatome and power supply occurred on 5 march 2019 and the technician found that the motor ran erratically on the dermatome, but was within motor speed specifications.The dermatome was further noted to be within side to side calibration specifications and have no visible damage.The power supply was found to be functioning as intended.Repair of the dermatome occurred the same day and involved replacing the motor, power switch, power cord assembly, and eccentric shaft.The technician then tested and verified that both the dermatome and the power supply were functioning as intended and the devices were returned to the customer without further incident.The dermatome and the power supply were tested, inspected, and repaired.Reference number (b)(4) on 13 february 2019.While the service technician does find that the motor on the dermatome was running erratically, the device was found to be running within motor speed specifications, meaning that the motor could not have turned off during testing.As such, the reported shutting off during use or the turning on issues could not be reproduced during testing.Therefore, based on the information provided, a specific root cause of the reported issues cannot be determined.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 was received.

• Brand Name: HANDPIECE, ELECTRIC DERMATOME
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8361958
• MDR Text Key: 136873920
• Report Number: 0001526350-2019-00124
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,user facility
• Type of Report: Initial,Followup
• Report Date: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00882100100
• Device Lot Number: 63924234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1