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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reference:(b)(4).Fractured drill bit was evaluated and the reported event was confirmed.Drill bit was inspected for the major diameter and web thickness and was found to be with specifications.Dhr was reviewed and no discrepancies were found.A root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Orthopediatrics will continue to monitor for trends.
Event or Problem Description
It has been reported that during the placement of a locking cannulated blade plate, a drill bit fractured.No pieces of the drill bit remained in the patient.No adverse events have been reported as a result of this malfunction.

• Brand Name: 2.5MM DRILL BIT
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): ORTHOPEDIATRICS, INC; 2850 frontier drive; warsaw, in
• MDR Report Key: 10059436
• Report Number: 3006460162-2020-00060
• Device Sequence Number: 2783012
• Product Code: HTW
• UDI-Device Identifier: 00841132122884
• UDI-Public: (01)00841132122884(10)91801381L
• 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): 05/14/2020

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: 91801381L
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 05/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 6 YR