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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 Unstable (1667)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/10/2023
Event Type  malfunction  
Manufacturer Narrative
This event is recorded by zimmer biomet under cmp-(b)(4).Review of the most recent repair record determined the rpms were out of specification on the low end.The motor, switch, plug harness assembly, motor seal, and needle bearing were replaced 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.G2, country event occurred in: australia.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.
 
Event Description
It was reported that, prior to surgery that the device had slow speed and a blown fuse on console.There was no harm or injury to patient as there was no patient involvement.Due diligence is complete.No additional information is available.No adverse event reported.
 
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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 Key18241610
MDR Text Key329580643
Report Number0001526350-2023-01568
Device Sequence Number1
Product Code GFD
UDI-Device Identifier00889024375994
UDI-Public(01)00889024375994(11)180815(10)64135952
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 11/30/2023
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 Number00882100100
Device Lot Number64135952
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2023
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/10/2023
Initial Date FDA Received11/30/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/29/2018
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
Treatment
00-8802-001-00.1" WIDTH PLATE.; 00-8802-002-00.2" WIDTH PLATE.; 00-8802-003-00.3" WIDTH PLATE.; 00-8802-004-00.4" WIDTH PLATE.; ITEM: 00882100600.POWER SUPPLY.SERIAL # (B)(6).
Patient SexPrefer Not To Disclose
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