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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. ZIMMER AIR DERMATOME; DERMATOME HANDPIECE, PNEUMATIC
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ZIMMER SURGICAL, INC. ZIMMER AIR DERMATOME; DERMATOME HANDPIECE, PNEUMATIC Back to Search Results
Model Number N/A
Device Problems Corroded (1131); Calibration Problem (2890); Material Deformation (2976); Material Integrity Problem (2978); Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/12/2023
Event Type  malfunction  
Manufacturer Narrative
This complaint is recorded by zimmer biomet under cmp-(b)(4).A follow up/ final report will be submitted once investigation is complete.
 
Event Description
It was reported that there was a control bar issue, calibration issue, damaged width plates, corroded reciprocation arm and corroded bearings.The event timing was during preventative maintenance.There was no harm or delay reported.No adverse events were reported as a result of this malfunction.Due diligence is complete and no additional information is available.
 
Manufacturer Narrative
Upon receipt of additional information, it has been determined that this device did not cause or contribute to a serious injury or a reportable malfunction.The initial report was forwarded in error and should be voided.
 
Event Description
Upon receipt of additional information, it has been determined that this device did not cause or contribute to a serious injury or a reportable malfunction.The initial report was forwarded in error and should be voided.
 
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Brand Name
ZIMMER AIR DERMATOME
Type of Device
DERMATOME HANDPIECE, PNEUMATIC
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 Key16743589
MDR Text Key313331183
Report Number0001526350-2023-00375
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
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/27/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2023
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 Number107882
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/31/2023
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received10/25/2023
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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