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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. DERMATOME AN HANDPIECE

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ZIMMER SURGICAL, INC. DERMATOME AN HANDPIECE Back to Search Results
Model Number N/A
Device Problems Material Too Rigid or Stiff (1544); Component Missing (2306)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/07/2021
Event Type  malfunction  
Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined that the unit's machined head was damaged and was missing a screw.However, the repair was not completed because flextronics is waiting on replacement parts to be shipped.Device is used for treatment.A definitive root cause cannot be determined.The event is confirmed.
 
Event Description
It was reported the screw is very tight in dermatome, would like a service.Investigation found that a screw was missing.No adverse event was reported as a result of this malfunction.
 
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Brand Name
DERMATOME AN HANDPIECE
Type of Device
DERMATOME
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
christina arnt
56 e. bell drive
warsaw, IN 46582
5745273773
MDR Report Key12245857
MDR Text Key264107626
Report Number0001526350-2021-00857
Device Sequence Number1
Product Code GFD
UDI-Device Identifier00888024464834
UDI-Public(01)00888024464834(11)190322(10)64367743
Combination Product (y/n)N
Reporter Country CodeEI
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number88710100
Device Lot Number64367743
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/07/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/26/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/22/2019
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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