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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP ORTHOPEDIATRICS 2.5MM CALIBRATED DRILL BIT BIT, DRILL

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ORTHOPEDIATRICS, CORP ORTHOPEDIATRICS 2.5MM CALIBRATED DRILL BIT BIT, DRILL Back to Search Results
Model Number N/A
Device Problem Fracture
Event Date 12/16/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). Customer has indicated that the product will not be returned to orthopediatrics for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

It has been reported that during the placement of a locking cannulated blade plate, a drill bit fractured. The fractured portion of the drill bit remains in the patient's bone. No adverse events have been reported as a result of the malfunction.

 
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Brand NameORTHOPEDIATRICS 2.5MM CALIBRATED DRILL BIT
Type of DeviceBIT, DRILL
Manufacturer (Section D)
ORTHOPEDIATRICS, CORP
2850 frontier drive
warsaw, in
Manufacturer (Section G)
ORTHOPEDIATRICS, CORP
2850 frontier drive
warsaw, in
Manufacturer Contact
leigh jessop
2850 frontier drive
warsaw, in  
2670872
MDR Report Key9720753
Report Number3006460162-2019-00093
Device Sequence Number1
Product CodeHTW
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/21/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/18/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number01-1050-0032
Device LOT Number91801381-L
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 Received12/24/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/06/2018
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 02/18/2020 Patient Sequence Number: 1
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