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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP 2.5 MM CALIBRATED DRILL BIT; SUGICAL DRILL BIT
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ORTHOPEDIATRICS, CORP 2.5 MM CALIBRATED DRILL BIT; SUGICAL DRILL BIT Back to Search Results
Model Number 01-1050-0032
Device Problem Fracture (1260)
Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Event Date 06/30/2020
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 while the surgeon was drilling the holes, the drill broke.The surgeon removed the tip of the broken drill using forceps and x-rays.There were no adverse consequences to the patient reported.
 
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Brand Name
2.5 MM CALIBRATED DRILL BIT
Type of Device
SUGICAL DRILL BIT
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 Key10396477
MDR Text Key202585599
Report Number3006460162-2020-00092
Device Sequence Number1
Product Code HTW
Combination Product (y/n)N
Reporter Country CodeSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other
Type of Report Initial
Report Date 08/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number01-1050-0032
Device Lot Number7680528
Was Device Available for Evaluation? No
Date Manufacturer Received07/15/2020
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age12 YR
Patient Weight60
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