MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP UNKNOWN ORTHOPEDIATRICS PEDINAIL RECON SCREW

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Fall (1848)

Event Date 02/23/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to orthopediatrics for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It has been reported that following a fall, the patient was admitted into the emergency room where it was discovered that the proximal locking screw of the implanted pedinail system had backed out.The patient was scheduled same day for a tibial fracture reduction and screw advancement.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Photographs of the x-rays were provided for review and confirm that the screw backed out of the nail.Device history records review could not be completed as the item and lot numbers were unknown.A complaint history review could not be completed as the item and lot numbers were unknown.Based on the information provided regarding the patients' medical history and that she had been admitted to the er due to a fall, it was determined the root cause is most likely due to human factors.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.

• Brand Name: UNKNOWN ORTHOPEDIATRICS PEDINAIL RECON SCREW
• Type of Device: UNKNOWN ORTHOPEDIATRICS PEDINAIL RECON SCREW
• Manufacturer (Section D): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw IN 46582
• MDR Report Key: 7367478
• MDR Text Key: 103405584
• Report Number: 3006460162-2018-00017
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K083726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/23/2018
• Initial Date FDA Received: 03/23/2018
• Supplement Dates Manufacturer Received: 04/02/2018
• Supplement Dates FDA Received: 04/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR