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

Model Number N/A

Device Problem Loss of Power (1475)

Patient Problem No Patient Involvement (2645)

Event Date 07/05/2019

Event Type  malfunction  

Manufacturer Narrative

The event recorded by zimmer biomet under (b)(4).Customer has indicated that product is in the process of being returned to zimmer biomet for investigation.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

It was reported that zimmer electric dermatome stops working after turning it on several times.This took place during kit inspection.No patient involvement.No adverse events were reported as a result of this malfunction.

Event Description

No additional event information available.

Manufacturer Narrative

This follow up report is being submitted to report additional information.Reported issue: on (b)(6) 2019, it was reported that the product does not work, to repair.Per follow up the product stops working after turning it on several times.The customer returned an electric dermatome device, serial number (b)(6), for evaluation.The customer also returned a power supply, 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.Medicrea/flextronics has not previously repaired/evaluated electric dermatome serial number (b)(6) as documented in the repair reports.Device evaluations results/investigation findings: product review of the electric dermatome by flextronics on july 29, 2019 revealed that the needle bearing was defective.The calibration was within specifications and the motor speed was below specifications.The control bar was in the correct position.Repair of the electric dermatome was performed by flextronics on august 12, 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.Probable cause/root cause: although the reported event was confirmed during inspection of the device, it cannot be determined from the information provided what caused the components 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 (ie/capa/scar/hhe/d).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, LINE-POWERED
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8862038
• MDR Text Key: 153858977
• Report Number: 0001526350-2019-00615
• 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: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• 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: 61991955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1