MAUDE Adverse Event Report: ORTHOPEDIATRICS, INC 2.5MM CANNULATED DRILL BIT; BIT, DRILL

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product is in process of being returned to orthopediatrics for investigation.
Event or Problem Description
It has been reported that during the placement of a locking cannulated blade plate, a drill bit fractured.No adverse events have been reported as a result of this malfunction.

• Brand Name: 2.5MM CANNULATED DRILL BIT
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): ORTHOPEDIATRICS, INC; 2850 frontier drive; warsaw, in
• MDR Report Key: 10014034
• Report Number: 3006460162-2020-00057
• Device Sequence Number: 19622883
• Product Code: HTW
• UDI-Device Identifier: 00841132122884
• UDI-Public: (01)00841132122884(10)0047-L
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01-1050-0032
• Device Lot Number: 00U47-L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 04/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 13 YR
• Patient Weight: 23