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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. HANDPIECE, ELECTRIC DERMATOME; DERMATOME HANDPIECE, ELECTRICALLY-POWERED

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ZIMMER SURGICAL, INC. HANDPIECE, ELECTRIC DERMATOME; DERMATOME HANDPIECE, ELECTRICALLY-POWERED Back to Search Results
Model Number N/A
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/20/2023
Event Type  malfunction  
Manufacturer Narrative
This complaint is recorded by zimmer biomet under (b)(4).G2: foreign country- china.Review of the most recent repair record determined the unit had low rpms, the wiring harness failed and the unit was out of calibration.The motor and plug harness assembly were replaced and resolved the reported issue.Dhr was reviewed and no discrepancies related to the reported event were found.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 device does not work properly.The event timing was pre operation.There was no harm or delay reported.Upon investigation, the unit had low rpms.No adverse events were reported as a result of this malfunction due diligence is complete and no additional information is available.
 
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Brand Name
HANDPIECE, ELECTRIC DERMATOME
Type of Device
DERMATOME HANDPIECE, ELECTRICALLY-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 Key17546182
MDR Text Key321259564
Report Number0001526350-2023-00918
Device Sequence Number1
Product Code GFD
UDI-Device Identifier00889024375994
UDI-Public(01)00889024375994(11)180108(10)63898207
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/14/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/14/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number00882100100
Device Lot Number63898207
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/10/2023
Was the Report Sent to FDA? No
Date Manufacturer Received08/11/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/16/2018
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
Patient SexPrefer Not To Disclose
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