MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. HANDPIECE, ELECTRIC DERMATOME; DERMATOME, LINE-POWERED

Model Number N/A

Device Problem Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Upon receipt of additional information, the product return and the investigation is complete, a follow up/final report will be submitted.

Event Description

Dermatome handle gets hot while using and the power of the dermatome decreases and the powered is lower than normal.This event was discovered upon routing checking outside of operation room.There was no patient involved, no one was harmed nor injured as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under cmp (b)(4).D4 udi: (b)(4).This medwatch is being filed to relay additional information.Reported issue: on 20 november 2019, it was reported that the dermatome handle gets hot while using and the power of the dermatome decreases.Powered lower than normal event was discovered upon routing checking outside of operation room.The customer returned an electric dermatome device, serial number (b)(6), for evaluation.Dhr review: 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.Device evaluations results/investigation findings: product review of the electric dermatome by zimmer biomet on 20 december 2019 revealed that the motor was warming and the rpm was not stable.It was also noted that the unit was out of calibration and the control bar was too thin.Repair of the electric dermatome was performed by zimmer biomet which included replacement of the motor, control bar, shaft bearings, and sleeve bearings.Electric dermatome, serial number (b)(6), was then tested and functioned properly.Probable cause/root cause: although the reported event was confirmed during inspection of the device, it cannot be determined what caused the motor to fail.Therefore, the root cause could not be determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Conclusion: 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

No additional event information available.

• Brand Name: HANDPIECE, ELECTRIC DERMATOME
• Type of Device: DERMATOME, LINE-POWERED
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 9465314
• MDR Text Key: 196211636
• Report Number: 0001526350-2019-01156
• 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: 02/04/2020

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 Model Number: N/A
• Device Catalogue Number: 00882100100
• Device Lot Number: 63394171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/20/2019
• Initial Date FDA Received: 12/13/2019
• Supplement Dates Manufacturer Received: 01/24/2020
• Supplement Dates FDA Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1