MAUDE Adverse Event Report: ORTHOPEDIATRICS, INC PEDINAIL 3.2MM PILOT DRILL

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/21/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.

Event Description

It has been reported that during the placement of an intramedullary nail, a drill bit fractured.All fragments of the drill bit were retrieved.No adverse events were reported as a result of this malfunction.

• Brand Name: PEDINAIL 3.2MM PILOT DRILL
• Type of Device: DRILL
• Manufacturer (Section D): ORTHOPEDIATRICS, INC; 2850 frontier drive; warsaw, in
• Manufacturer (Section G): ORTHOPEDIATRICS, INC; 2850 frontier drive; warsaw, in
• Manufacturer Contact: kriss anderson ; 2850 frontier drive; warsaw, in ; 2670872
• MDR Report Key: 9978799
• MDR Text Key: 190837538
• Report Number: 3006460162-2020-00053
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 00841132123591
• UDI-Public: (01)00841132123591(10)OP-91900779-E
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/20/2020

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01-1500-9015
• Device Lot Number: OP-91900779-E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2020
• Initial Date FDA Received: 04/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 13 YR
• Patient Weight: 73