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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. ZIMMER AIR DERMATOME

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ZIMMER SURGICAL, INC. ZIMMER AIR DERMATOME Back to Search Results
Model Number N/A
Device Problem Loss of Power (1475)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/23/2017
Event Type  malfunction  
Manufacturer Narrative
This event has been recorded by zimmer biomet under cmp-(b)(4).On (b)(6) 2017, it was reported that the product lacks power and stops.The customer returned an air dermatome device, serial number (b)(4), for evaluation.The device history record (dhr) review noted no related non-conformances, requests for deviation (rfd), change notices (cn) or any other issues with manufacturing.The dhr review found no issues with the device and all verifications, inspections and tests were successfully completed.Medicrea has not previously repaired/evaluated air dermatome serial number (b)(4) as documented in the repair reports in (b)(4).Initial qa inspection of the air dermatome by medicrea on february 2, 2017 revealed that the motor and swivel are completely corroded and worn.It was also revealed that the eccentric shaft, the thickness control shaft, the control bar were twisted and the head is damaged especially on the cutting space.Repair of the air dermatome was not performed by medicrea on april 27, 2017 customer denied the repair quotation and requested to destroy the device on april 28, 2017.The reported event was confirmed since during initial inspection it was revealed that the motor and swivel are completely corroded and worn.However, it was also revealed that the eccentric shaft, the thickness control shaft, the control bar were twisted and the head is damaged especially on the cutting space.The root cause of the reported event was due to the motor which is completely worn and corroded.However, it was also revealed that the eccentric shaft, the thickness control shaft, the control bar were twisted and the head is damaged especially on the cutting space.The device was not repaired as the customer denied the repair quotation.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.
 
Event Description
It was reported that the product was lacking power and stopping during surgery.There was a short delay of 5-15 minutes.No adverse events were reported as a result of this malfunction.
 
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Brand Name
ZIMMER AIR DERMATOME
Type of Device
DERMATOME
Manufacturer (Section D)
ZIMMER SURGICAL, INC.
200 west ohio avenue
dover OH 44622
Manufacturer (Section G)
ZIMMER SURGICAL, INC.
200 west ohio avenue
dover OH 44622
Manufacturer Contact
christina arnt
56 e. bell drive
warsaw, IN 46582
5745273773
MDR Report Key7070219
MDR Text Key94204876
Report Number0001526350-2017-00911
Device Sequence Number1
Product Code GFD
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
PEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other
Type of Report Initial
Report Date 11/29/2017
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 NumberN/A
Device Catalogue Number00880100100
Device Lot Number32453000
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2017
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/28/2017
Initial Date FDA Received11/30/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/25/2000
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Removal/Correction NumberN/A
Patient Sequence Number1
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