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

Catalog Number 00882100100

Device Problem Loss of Power (1475)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/10/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The customer has indicated that the device is in process of being returned for evaluation and investigation is in process.Once the investigation is completed, a supplemental report will be filed accordingly.

Event Description

The device stops during its work.No adverse events have been reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The device history record (dhr) review was unable to be performed as the dhr associated with this device is not available.This device was manufactured prior to may 2009 where it was identified a robust dhr indexing and handling process was not in place.A corrective and preventative action (capa) implemented a serial number logbook to correct this issue.The previous repair record for zimmer air dermatome serial number (b)(6) was reviewed and noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with the device.The record review found no issues with the device and all verifications, inspections, and tests were successfully completed.No complaint history search based on the lot number and manufacturing date was performed for the above keywords as neither of these could be acquired through the information provided nor were able to be obtained through follow-up.In addition, it cannot be determined if there were any similar event related to the reported device based on the information provided.As such, no further actions are required at this time.The reported event was confirmed by the service technician who performed the evaluation and repair.On 17 april 2019, it was reported that a dermatome would slow down until it stopped during use.The customer returned a zimmer electric dermatome serial number (b)(6) for evaluation.Evaluation of the device on 29 may 2019 noted that the dermatome was out of calibration at the zero setting and that the control bar was not in the correct position.Upon further evaluation, it was found that the motor was defective and that the device did not run.Repair of the dermatome occurred on 14 august 2019 and involved replacing multiple bearings, the control bar, spring seal, motor, and multiple screws as well as recalibrating the device and positioning the control bar.The technician then tested and verified that the dermatome was functioning as intended, then returned the device to the customer without further incident.The device was tested, inspected, and repaired.While the service technician found a defective motor on the device, which can a cause the loss of motor speed during use, it cannot be determined from the information provided as to what caused the motor to malfunction.Therefore, a specific root cause of the reported event 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.Review of the information provided during the investigation determined that there are no further actions needed at this time.This complaint will be tracked and trended for any adverse trends that may warrant further action.

Event Description

It was reported that during surgery the dermatome slows down until stop.Other unspecified dermatome has been used to complete the surgery.There is no impact to patient and no surgical delays.No additional event information is available.

• 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: 8541626
• MDR Text Key: 142814976
• Report Number: 0001526350-2019-00274
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 08/28/2019

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: 00882100100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/10/2019
• Initial Date FDA Received: 04/23/2019
• Supplement Dates Manufacturer Received: 08/27/2019
• Supplement Dates FDA Received: 08/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1