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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 Problems Component Missing (2306); Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/08/2022
Event Type  malfunction  
Event Description
It was reported that during unknown timing, the product was determined to need service and it was missing parts.No harm or delay was noted.During product evaluation, it was found that the motor speed was unstable.Due diligence is complete as multiple attempts were made; however, no further information is available.As no additional information is available, we are unable to provide further information.No adverse events are associated with this malfunction.
 
Manufacturer Narrative
This complaint is recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined the motor speed was unstable and the motor had signs of corrosion, the needle bearing was worn, and some screws were not original.The control bar was not in the correct position and the unit was not calibrated.The motor, needle bearing, and screws were replaced and the control bar position and unit were recalibrated to resolve 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 trends.E1: telephone number: (b)(6).
 
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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 Key16693510
MDR Text Key312819989
Report Number0001526350-2023-00343
Device Sequence Number1
Product Code GFD
Combination Product (y/n)N
Reporter Country CodeSF
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 04/06/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2023
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 Number61968505
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/08/2022
Was the Report Sent to FDA? No
Date Manufacturer Received04/06/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/31/2012
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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