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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOPEDIATRICS, INC 5.0MM CANNULATED DRILL BIT BIT, DRILL

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ORTHOPEDIATRICS, INC 5.0MM CANNULATED DRILL BIT BIT, DRILL Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/12/2019
Event Type  Malfunction  
Manufacturer Narrative

Reference: (b)(4). Instrument has not been returned to orthopediatrics for evaluation.

 
Event Description

It has been reported that during the placement of a cannulated screw, a drill bit fractured when it made contact with the bone cortex. The drill bit pieces were removed. A delay greater than thirty minutes was noted. No adverse events have been reported as a result of the malfunction.

 
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Brand Name5.0MM CANNULATED DRILL BIT
Type of DeviceBIT, DRILL
Manufacturer (Section D)
ORTHOPEDIATRICS, INC
2850 frontier drive
warsaw, in
Manufacturer (Section G)
ORTHOPEDIATRICS, INC
2850 frontier drive
warsaw, in
Manufacturer Contact
leigh jessop
2850 frontier drive
warsaw, in 
2670872
MDR Report Key9696371
MDR Text Key190670736
Report Number3006460162-2019-00059
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,Followup
Report Date 02/07/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/11/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number01-1071-038
Device LOT Number72977-B
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/12/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/18/2018
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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