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

Model Number N/A

Device Problem Failure to Cut (2587)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (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

It was reported there was problem with the blade.It was not in contact with the dermatome.As a result of the device malfunction there was 16-30 delay while patient was under anesthesia.There was an alternate device available and used to complete the surgery.No additional consequences have been 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).On (b)(6) 2019, it was reported that the blade is not in contact with the dermatome.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 (b)(6) 2019 revealed that the needle bearing was defective.The power cord assembly was damaged and the motor was corroded.The calibration and motor speed were within specifications and the control bar was in the correct position.The customer did not return a power supply for evaluation.Repair of the electric dermatome was performed by flextronics on (b)(6) 2019 which included replacement of the motor, plug harness assembly, 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 never confirmed during inspection of the device.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.Review of the information provided during the investigation determined that there are no further actions needed at this time (ie/capa/scar/hhe/d).This complaint will be tracked and trended for any adverse trends that may warrant further action.

• 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: 8937218
• MDR Text Key: 155781079
• Report Number: 0001526350-2019-00716
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• 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: 62976464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other