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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 Incorrect Measurement (1383); Mechanical Problem (1384); Failure to Cut (2587); Activation Problem (4042)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/17/2022
Event Type  malfunction  
Event Description
It was reported that during surgery the reciprocation arm had no movement, and the skin was taken irregularly.There is no known impact or consequence to the patient.Attempts have been made and no further information has been provided.
 
Manufacturer Narrative
(b)(4).Report source - foreign: (b)(6).The product has been returned to zimmer biomet, and the investigation is in process.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Investigation incomplete.
 
Manufacturer Narrative
Upon receipt of additional information, it has been determined that this device did not cause or contribute to a serious injury or a reportable malfunction.The initial report was forwarded in error and should be voided.
 
Event Description
Upon receipt of additional information, it has been determined that this device did not cause or contribute to a serious injury or a reportable malfunction.The initial report was forwarded in error and should be voided.
 
Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).E1 telephone number (b)(6).Investigation is completed.This is an initial final report submission.Review of the most recent repair record identified the following related repair: tech confirmed that the unit rpms were out of specification at the low end, the calibration was out at the 12 reading, and the thickness control lever was loose.Tech replaced the thickness control lever, reciprocating arm, motor, fine adjustment cams, bearings, carrier, and spring seal.The unit was tested, calibrated, and returned to the customer.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.
 
Event Description
It was reported that the reciprocation arm had no movement.There was no issue with the skin and the issue occurred outside the surgical environment.There is no known impact or consequence to the patient.At product evaluation investigation the unit rpms were out of specification at the low end.Due diligence is complete and no additional information is available.
 
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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
jennifer rapsavage
56 e. bell drive
warsaw, IN 46582
5745260384
MDR Report Key15413838
MDR Text Key300091721
Report Number0001526350-2022-00895
Device Sequence Number1
Product Code GFD
UDI-Device Identifier00889024464834
UDI-Public(01)00889024464834(11)190914(10)64479606
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 01/17/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/13/2022
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 Number64479606
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/02/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/04/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/14/2019
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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