MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP 3.5 MM LOCKING CORTICAL SCREW W/T15 HEXALOBE, 55MM; LOCKING PROXIMAL FEMUR CORTICAL SCREW

Model Number 00-0903-2655

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/08/2020

Event Type  malfunction  

Manufacturer Narrative

Customer has indicated that the product will not be returned to orthopediatrics for investigation, because the device is still implanted.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found for the wire guide.No lot number was provided for the devices used, so no further dhr evaluation could be performed.Review of the complaint history determined that no further action is required as no were trends identified.Root cause was unable to be determined.Multiple mdr reports were filed for this event, please see associated reports: 3006460162-2020-00080 and 3006460162-2020-00082.Reference: (b)(4).

Event Description

It was reported that two cannulated screws failed to lock to the locking proximal femur plate.The remaining screws locked correctly to the plate.The surgeon replaced the two screws with additional screws which locked correctly.No adverse events have been reported as a result of the malfunction.

• Brand Name: 3.5 MM LOCKING CORTICAL SCREW W/T15 HEXALOBE, 55MM
• Type of Device: LOCKING PROXIMAL FEMUR CORTICAL SCREW
• Manufacturer (Section D): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw, in
• Manufacturer (Section G): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw, in
• Manufacturer Contact: kriss anderson ; 2850 frontier drive; warsaw, in ; 2686379
• MDR Report Key: 10277691
• MDR Text Key: 232043946
• Report Number: 3006460162-2020-00081
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162307
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 00-0903-2655
• Device Catalogue Number: 00-0903-2655
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/19/2020
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1