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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. ZIMMER AIR DERMATOME; DERMATOME PNEUMATICALLY-POWERED

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ZIMMER SURGICAL, INC. ZIMMER AIR DERMATOME; DERMATOME PNEUMATICALLY-POWERED Back to Search Results
Model Number N/A
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/08/2022
Event Type  malfunction  
Manufacturer Narrative
This incident has been recorded under (b)(4).Review of the most recent repair record determined the unit was out of calibration, the position of the control bar was not correct and the width plates were damaged.The position of the control bar was recalibrated and resolved the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The event is confirmed.If any further information is found which would change or alter any conclusions or information a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trend.
 
Event Description
It was reported that the depth switch on the handpiece was unable to be adjusted.No patient involvement was noted.Upon evaluation it was noted that the width plate were damaged.No other adverse events were reported as it relates to the event.
 
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Brand Name
ZIMMER AIR DERMATOME
Type of Device
DERMATOME PNEUMATICALLY-POWERED
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
jennifer rapsavage
56 e. bell drive
warsaw, IN 46582
5745260384
MDR Report Key15217919
MDR Text Key302575372
Report Number0001526350-2022-00780
Device Sequence Number1
Product Code GFD
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Physician
Type of Report Initial
Report Date 08/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2022
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 Number33265300
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/19/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/09/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/31/2002
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A
Patient Sequence Number1
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