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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOPEDIATRICS, INC 2.5 CALIBRATED DRILL BIT BIT, DRILL
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ORTHOPEDIATRICS, INC 2.5 CALIBRATED DRILL BIT BIT, DRILL Back to Search Results
Model Number N/A
Device Problem Fracture
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Complaint sample was not returned for evaluation. Reported event was not confirmed. The dhr was reviewed and there were no process deviations that would have contributed to the failure. Risk management file review was deemed appropriate. Review of the complaint history determined that no further action is required as there were no trends identified. Root cause was unable to be determined.

 
Event Description

It was reported that during a fracture correction, the drill bit fractured inside the cancellous bone. The fractured portion of the drill bit remained in the patient's bone. A new drill bit was used to drill a new hole for the screw to be implanted. No adverse events have been reported as a result of the malfunction.

 
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Brand Name2.5 CALIBRATED 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
warsa, in  
2670872
MDR Report Key9742959
Report Number3006460162-2019-00031
Device Sequence Number1
Product CodeHTW
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation
Type of Report Initial
Report Date 07/06/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/23/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number01-1050-0032
Device LOT Number00SKA-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 Received06/06/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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