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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDARTIS INC NEXTRA CH CANNULATED HAMMERTOE SYSTEM; SCREW
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MEDARTIS INC NEXTRA CH CANNULATED HAMMERTOE SYSTEM; SCREW Back to Search Results
Catalog Number CH-32P-KT
Device Problem Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/03/2022
Event Type  malfunction  
Manufacturer Narrative
If addtional information is provided that changes the outcome of the investigation a follow-up report will be filed.
 
Event Description
The mid implant should put into prox implant and have a friction fixation.There was not enough fixation for the implants to stay together.The surgeon tried a larger mid implant.Same result.So surgeon removed implants to return to zb.
 
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Brand Name
NEXTRA CH CANNULATED HAMMERTOE SYSTEM
Type of Device
SCREW
Manufacturer (Section D)
MEDARTIS INC
1195 polk drive
warsaw IN 46582
Manufacturer (Section G)
MEDARTIS INC
1195 polk drive
warsaw IN 46582
Manufacturer Contact
travis christman
1195 polk drive
warsaw, IN 46582
5743762404
MDR Report Key16299616
MDR Text Key309266519
Report Number3009540749-2023-00002
Device Sequence Number1
Product Code HWC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K221610
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/03/2022
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? No
Device Catalogue NumberCH-32P-KT
Device Lot Number168101
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/10/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/05/2023
Initial Date FDA Received02/03/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
CH-35M LOT 1574804; CH-425M 1574805
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