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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOPEDIATRICS, INC PEDINAIL 3.2MM PILOT DRILL

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ORTHOPEDIATRICS, INC PEDINAIL 3.2MM PILOT DRILL Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/21/2020
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). The device will not be returned for analysis; however, an investigation of the reported event is in progress.

 
Event Description

It has been reported that during the placement of an intramedullary nail, a drill bit fractured. All fragments of the drill bit were retrieved. No adverse events were reported as a result of this malfunction.

 
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Brand NamePEDINAIL 3.2MM PILOT DRILL
Type of DeviceDRILL
Manufacturer (Section D)
ORTHOPEDIATRICS, INC
2850 frontier drive
warsaw, in
Manufacturer (Section G)
ORTHOPEDIATRICS, INC
2850 frontier drive
warsaw, in
Manufacturer Contact
kriss anderson
2850 frontier drive
warsaw, in 
2670872
MDR Report Key9978799
MDR Text Key190837538
Report Number3006460162-2020-00053
Device Sequence Number1
Product Code HTW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation
Type of Report Initial
Report Date 04/20/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/20/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number01-1500-9015
Device LOT NumberOP-91900779-E
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/21/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/20/2020 Patient Sequence Number: 1
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