MAUDE Adverse Event Report: ORTHOPEDIATRICS UNKNOWN ORTHOPEDIATRICS PEDINAIL IM FEMORAL NAIL; PEDINAIL IM NAIL

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 11/21/2017

Event Type  Injury  

Manufacturer Narrative

Reference: (b)(4).Concomitant medical devices: unknown pedinail recon screw, item #: unknown, lot #: unknown.(b)(6).The device has not yet been returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3006460162-2017-00032.

Event Description

It was reported that following the implantation of an intramedullary nail, follow-up x-rays discovered that the im nail and screw fractured at the proximal screw hole.The diagnosis was made three years post operatively.The patient has been scheduled for a revision procedure at an unknown date.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: UNKNOWN ORTHOPEDIATRICS PEDINAIL IM FEMORAL NAIL
• Type of Device: PEDINAIL IM NAIL
• Manufacturer (Section D): ORTHOPEDIATRICS; 2850 frontier drive; warsaw IN 46582
• Manufacturer (Section G): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw IN 46582
• Manufacturer Contact: leigh jessop ; 2850 frontier drive; warsaw, IN 46582 ; 5742670872
• MDR Report Key: 7153461
• MDR Text Key: 96003170
• Report Number: 3006460162-2017-00031
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K083726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2017

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: Physician
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/28/2017
• Initial Date FDA Received: 12/28/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 16 YR