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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. ZIMMER AIR DERMATOME

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ZIMMER SURGICAL, INC. ZIMMER AIR DERMATOME Back to Search Results
Model Number N/A
Device Problems Failure to Cut (2587); Patient Device Interaction Problem (4001)
Patient Problem Laceration(s) (1946)
Event Date 04/17/2024
Event Type  Injury  
Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).G2, country event occurred in: canada.The product is in the process of being evaluated by zimmer biomet.Once the product investigation has been completed, a follow up/final report will be submitted.
 
Event Description
It was reported that during surgery on that when taking a skin graft the skin seemed to catch on the surface of the guard pulling the dermatome downward and causing a laceration.There was harm or injury to patient due to the laceration, additional skin graft harvested, and sutures were required.Part of the original graft was useable.There was an unspecified delay during the procedure while the patient was under anesthesia.The procedure was completed using an alternate device.Due diligence is complete.No additional information is available.
 
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Brand Name
ZIMMER AIR DERMATOME
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
jennifer rapsavage
56 e. bell drive
warsaw, IN 46582
5745260384
MDR Report Key19203247
MDR Text Key341288163
Report Number0001526350-2024-00490
Device Sequence Number1
Product Code GFD
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Nurse
Type of Report Initial
Report Date 04/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number00880100100
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/19/2024
Initial Date FDA Received04/29/2024
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
ITEM: 00880100100.SERIAL: (B)(6).
Patient Outcome(s) Required Intervention;
Patient SexPrefer Not To Disclose
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