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U.S. Department of Health and Human Services

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

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ZIMMER SURGICAL, INC. ZIMMER AIR DERMATOME; DERMATOME HANDPIECE, PNEUMATIC Back to Search Results
Model Number N/A
Device Problems Failure to Cut (2587); Gas/Air Leak (2946); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/17/2023
Event Type  malfunction  
Event Description
It was reported that the unit was not shaving skin effectively (stick) and leak in hose.There is no information provided regarding the timing of the event or if there was any patient involvement/harm that may have occurred.No adverse events were reported as a result of this malfunction.Due diligence is in progress, no further information is available.
 
Manufacturer Narrative
An investigation into the reported event has been initiated under (b)(4).Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.G2: foreign: australia.
 
Event Description
There is no additional information available.
 
Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).The following sections have been corrected/updated: b4, b5, d2, d4, g1, g3, g6, h1, h2, h3, h4, h6, and h10.Review of the most recent repair record determined the motor was not working properly, the unit had low rpms and the hose had a leak.The motor, motor sleeve, ball bearing, set screw, swivel, spring, ball bearing and needle bearing were replaced and it is recommended the hose be replaced and resolved the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.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.
 
Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.
 
Event Description
It was reported that the event occurred during surgery.There was no patient harm or surgical delay reported.An alternate device was available for immediate use.Due diligence is complete, no further information is available.
 
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Brand Name
ZIMMER AIR DERMATOME
Type of Device
DERMATOME HANDPIECE, PNEUMATIC
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 Key18111362
MDR Text Key327893664
Report Number0001526350-2023-01495
Device Sequence Number1
Product Code GFD
UDI-Device Identifier00889024375901
UDI-Public(01)00889024375901(11)181211(10)64240706
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 Nurse
Type of Report Initial,Followup,Followup
Report Date 11/27/2023
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 Number00880100100
Device Lot Number64240706
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/26/2023
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/19/2023
Initial Date FDA Received11/10/2023
Supplement Dates Manufacturer Received11/14/2023
11/27/2023
Supplement Dates FDA Received11/17/2023
11/28/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/17/2018
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
UNK BLADELN: UNK; UNKNOWN HOSE
Patient SexPrefer Not To Disclose
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