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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP PNP ADOLESCENT NAIL INTRAMEDULLARY NAIL

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ORTHOPEDIATRICS, CORP PNP ADOLESCENT NAIL INTRAMEDULLARY NAIL Back to Search Results
Model Number 00-1503-1042
Device Problem Fracture (1260)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 07/08/2020
Event Type  malfunction  
Manufacturer Narrative
Customer has indicated that the product is in process of being returned to orthopediatrics for investigation. Once the investigation has been completed, a follow-up mdr will be submitted. (b)(4).
 
Event Description
It was reported that the tip of the intramedullary nail broke off in the patient. No adverse events have been reported as a result of the malfunction.
 
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Brand NamePNP ADOLESCENT NAIL
Type of DeviceINTRAMEDULLARY NAIL
Manufacturer (Section D)
ORTHOPEDIATRICS, CORP
2850 frontier drive
warsaw, in
Manufacturer (Section G)
ORTHOPEDIATRICS, CORP
2850 frontier drive
warsaw, in
Manufacturer Contact
kriss anderson
2850 frontier drive
warsaw, in 
2686379
MDR Report Key10382227
MDR Text Key207376164
Report Number3006460162-2020-00088
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172583
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 07/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number00-1503-1042
Device Catalogue Number00-1503-1042
Device Lot Number175630-B
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/10/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/12/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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