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

Model Number 01-1050-0032

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/28/2020

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, follow-up mdr will be submitted.Reference: (b)(4).

Event Description

It was reported that the 2.5mm calibrated drill bit broke intraoperatively.

• Brand Name: 2.5MM CALIBRATED DRILL BIT
• Type of Device: 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 ; 2670897
• MDR Report Key: 10264259
• MDR Text Key: 198595487
• Report Number: 3006460162-2020-00078
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K111086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 01-1050-0032
• Device Lot Number: 91703973-L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/28/2020
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 8 YR
• Patient Weight: 30