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U.S. Department of Health and Human Services

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

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ZIMMER SURGICAL, INC. HANDPIECE, ELECTRIC DERMATOME; DERMATOME, LINE-POWERED Back to Search Results
Model Number N/A
Device Problems Patient Device Interaction Problem (4001); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/23/2021
Event Type  Injury  
Manufacturer Narrative
This complaint is recorded by zimmer biomet under (b)(4).A follow up/ final report will be submitted once investigation is complete.
 
Event Description
It was reported that during the operation, it was found that the electric leather cutter was damaged.When the switch handle was powered on, the motor did not vibrate, and the blade did not move.The motor seemed to have been stuck.Hence, another skin graft was taken manually from the patient.There was no delay involved.No additional patient consequences were reported.
 
Event Description
No additional event information.
 
Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.The following sections have been updated: review of the most recent repair record could not be completed because the device was not returned for evaluation and repair.Review of the device history record identified no deviations or anomalies during manufacturing.Device is used for treatment.Review of complaint history identified additional similar complaints for the reported item and no additional complaints for the reported part and lot combination.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The event cannot be confirmed.Per the ifu, the dermatome should be "returned every 12 months for inspection and preventive maintenance.Annual factory calibration checks are strongly recommended to verify continued accuracy".
 
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Brand Name
HANDPIECE, ELECTRIC DERMATOME
Type of Device
DERMATOME, LINE-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
christina arnt
56 e. bell drive
warsaw, IN 46582
5745273773
MDR Report Key12287883
MDR Text Key265388946
Report Number0001526350-2021-00891
Device Sequence Number1
Product Code GFD
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,User Facility,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/10/2022
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 Number00882100100
Device Lot Number61897055
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/30/2021
Initial Date FDA Received08/06/2021
Supplement Dates Manufacturer Received12/30/2021
Supplement Dates FDA Received01/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/31/2011
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 Outcome(s) Other;
Patient Age46 YR
Patient SexFemale
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