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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. HANDPIECE, ELECTRIC DERMATOME
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ZIMMER SURGICAL, INC. HANDPIECE, ELECTRIC DERMATOME Back to Search Results
Catalog Number 00882100100
Device Problems Overheating of Device (1437); Power Problem (3010)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/05/2019
Event Type  malfunction  
Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet.Once the product is returned and the investigation is complete, a follow up/final report will be submitted.
 
Event Description
Dermatome had been returned with information that it works intermittently and the power cable heats up approx.60-70 cm from the plug during operation.There was no harm or delay involved.No adverse events were reported as a result of this malfunction.
 
Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet.Once the product is returned and the investigation is complete, a follow up/final report will be submitted.
 
Event Description
It was reported that the dermatome had been returned with information that it works intermittently, and the power cable heats up approx.60-70 cm from the plug during operation.There was no harm or delay involved.There were no burns/harm/injury due to the malfunction, and no additional graft was needed.No adverse events were reported as a result of this malfunction.
 
Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).On 12 august 2019, it was reported that a dermatome would not work intermittently and that the power cable would heat up during use.The customer returned a zimmer electric dermatome serial number (b)(4) for evaluation of the device on 28 august 2019 noted that the interior cable of the plug harness assembly was damaged and that the device was out of calibration at the 0, 10, and 20 settings.Upon further evaluation, it was found that the motor ran above motor speed specifications and that there was a defective needle bearing on the device.Repair of the dermatome occurred on 9 september 2019 and involved replacing the motor, shaft and sleeve bearings, needle bearing and the plug harness assembly as well as recalibrating the device.The technician then tested and verified that the device was functioning as intended, then returned the device to the customer without further incident.While the service technician found that the power cable was damaged, which could cause the inside of the cord to heat up during use, and that the motor was running above motor speed specifications, it cannot be determined from the information provided as to what caused the damage to the power cord and what caused the motor to break down such that it was not running at a speed.As such, a specific root cause of the reported issues 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.
 
Event Description
No additional event information available.
 
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Brand Name
HANDPIECE, ELECTRIC DERMATOME
Type of Device
DERMATOME
Manufacturer (Section D)
ZIMMER SURGICAL, INC.
200 west ohio avenue
dover OH 44622
MDR Report Key8974005
MDR Text Key156933675
Report Number0001526350-2019-00752
Device Sequence Number1
Product Code GFD
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 11/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number00882100100
Device Lot Number31957900
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/26/2019
Was the Report Sent to FDA? No
Date Manufacturer Received11/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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