MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP LOCKING SCREW; PEDINAIL

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/05/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint sample was not returned for evaluation.Reported event was not confirmed.Dhr review was unable to be performed as the lot number of the involved device is unknown.Risk management file review was deemed appropriate.Review of the complaint history determined that no further action is required as there were no trends identified.Root cause was unable to be determined.(b)(4) addresses the extraction adaptor, bullet tip.

Event Description

It was reported that during a scheduled hardware removal, the distal locking screw fractured when the surgeon was tapping the screw from lateral to medial.No adverse events have been reported as a result of the malfunction.

• Brand Name: LOCKING SCREW
• Type of Device: PEDINAIL
• Manufacturer (Section D): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw, in
• Manufacturer (Section G): ORTHOPEDIATRICS, INC; 2850 frontier drive; warsaw, in
• Manufacturer Contact: leigh jessop ; 2850 frontier drive; warsaw, in ; 2670872
• MDR Report Key: 9721967
• MDR Text Key: 190696107
• Report Number: 3006460162-2020-00023
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083726
• 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: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2019
• 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 Weight: 50