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

Catalog Number 00882100100

Device Problems Device Emits Odor (1425); Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Report source: foreign - (b)(6).The investigation is still in progress.Once the investigation is complete a follow up mdr will be submitted.

Event Description

The product stop after 5 min of use and impossible to continue despite the activation of the trigger.The event occurred during surgery.There was a loss of power and a burning smell.No additional information received.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).D4 - udi# - (b)(4).Conclusion summary: on may 28, 2019, it was reported that the product stops after 5 minutes of use and it is impossible to continue despite the activation of the trigger.The event occurred during surgery.There was a loss of power and a burning smell.The customer returned an electric dermatome device, serial number (b)(6), for evaluation.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.Medicrea/flextronics has not previously repaired/evaluated electric dermatome serial number (b)(6) as documented in the repair reports in livelink.Product review of the electric dermatome by flextronics on june 13, 2019 revealed that the needle bearing was defective.The calibration was out of specifications at the zero setting only.The control bar was not in the correct position and the motor did not run.The customer did not return a power supply for evaluation.Repair of the electric dermatome was performed by flextronics on june 14, 2019 which included replacement of the motor and needle bearing.Electric dermatome, serial number (b)(6), was then tested and functioned properly.It was repaired, inspected and tested.The reported event was confirmed since during the product review by flextronics it was noted that the motor did not run.The root cause of the reported event could not be specifically determined with the information that was provided.During the product review by flextronics it was noted that the motor did not run.It is unknown with the information that was provided how this occurred.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.

• 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: 8697348
• MDR Text Key: 148071162
• Report Number: 0001526350-2019-00477
• 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: 08/14/2019

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: 64025426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1