MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP UNKNOWN PEDIFLEX FLEXIBLE IM NAIL; PIN, FIXATION, SMOOTH

Model Number N/A

Device Problem Material Twisted/Bent (2981)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: this event was reported in (b)(4).The product has not been returned to orthopediatrics.The investigation is in process.

Event Description

It has been reported that during a removal of a felxible intramedullary nail, the tip was noted to be bent.No patient consequences were reported.

• Brand Name: UNKNOWN PEDIFLEX FLEXIBLE IM NAIL
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw, in
• Manufacturer (Section G): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw, in
• Manufacturer Contact: leigh jessop ; 2850 frontier drive; warsaw, in ; 2670872
• MDR Report Key: 9717723
• MDR Text Key: 190695341
• Report Number: 3006460162-2020-00002
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081097
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/13/2020

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/18/2019
• Initial Date FDA Received: 02/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1