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

Catalog Number 00882100100

Device Problem Misassembly by Users (3133)

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

Event Type  malfunction  

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

Dermatome failure.The blade is difficult to place, the event occurred before surgery.No adverse events were reported as a result of this malfunction.

Event Description

No additional event information.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.D4: udi #: (b)(4).The device history record for zimmer electric 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 manufacturing.The record review found no issues with the device and all verifications, inspections, and tests were successfully completed.Using the machine-repair reports and the repair sites folders on livelink as well as sap to query for all repairs on serial number (b)(6) prior to 23 may 2019, the device was noted to have not been previously repaired.The reported event was confirmed by the service technician who performed the evaluation and repair.On 23 may 2019, it was reported that it was difficult to place a blade on a dermatome.The customer returned a zimmer electric dermatome serial number (b)(6) for evaluation.Evaluation of the device on 5 june 2019 found that the device was out of calibration at the zero setting and the control bar was not in the correct position.Upon further evaluation, it was found that the dermatome was running below motor speed specifications and that there was a damaged cable.Repair of the dermatome occurred on 13 june 2019 and involved replacing the plug harness assembly, screws, multiple bearing and the motor as well as recalibrating the device and reposition the control bar.The technician then tested and verified that the dermatome was functioning as intended.The device was then returned to the customer without further incident.The device was tested, inspected, and repaired.While the service technician does find that the control bar was out of position, which would prevent the blade from being placed on the dermatome as intended, it cannot be determined from the information provided as to what caused the control bar to fall out of position.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.

• Brand Name: ZIMMER ELECTRIC DERMATOME HP
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8697576
• MDR Text Key: 148075201
• Report Number: 0001526350-2019-00472
• 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: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00882100100
• Device Lot Number: 63526314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1