MAUDE Adverse Event Report: ORTHOPEDIATRICS, INC ORTHOPEDIATRICS 3.5MM LOCKING CORTICAL SCREW, T15 HEX, 50MM

Model Number N/A

Device Problem Bent (1059)

Patient Problem No Information (3190)

Event Date 05/18/2018

Event Type  Injury  

Manufacturer Narrative

Reference: (b)(4).Concomitant devices - item: 00-1050-7004, 3.5mm 80 degree dfos plate, 5 degree flare, no offset, 4 hole, lot: 171000-c; item: 00-0903-2650, 3.5mm locking cortical screw, t15 hex, 50mm, lot: 162818-j - quantity: 1; item: 00-0903-2648, 3.5mm locking cortical screw, t15 hex, 48mm, lot: 160996-j; item: 00-0903-2530, 3.5mm self tapping cortical screw, t15 hex, size 30mm, lot: 163725-j; item: 00-0903-2534, 3.5mm self tapping cortical screw, t15 hex, size 34mm, lot: 164341-j; item: 00-0903-2532, 3.5mm self tapping cortical screw, t15 hex, size 32mm, lot: 152163-j.The complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3006460162-2018-00043, 3006460162-2018-00044, and 3006460162-2018-00045.

Event Description

It has been reported that following a surgical procedure to correct a valgus deformity of the distal femur, the implanted plate was found to have subsided into flexion.The patient underwent a revision procedure where it was discovered that three distal locking screws had bent.No additional patient consequences were reported.

Manufacturer Narrative

This follow is being submitted to relay additional information.Updated: h4 updated (b)(6)2016.H6 updated method 10, 4109, 4110 and 3331.H6 updated results 3211.H6 updated conclusion 4315.Complaint sample was returned for evaluation.Reported event was not confirmed.There were no process deviations that would have contributed to the failure.There were no recent design changes prior to manufacturing.Risk management file review was deemed appropriate.Root cause was unable to be determined.

• Brand Name: ORTHOPEDIATRICS 3.5MM LOCKING CORTICAL SCREW, T15 HEX, 50MM
• Type of Device: LOCKING CORTICAL SCREW
• Manufacturer (Section D): ORTHOPEDIATRICS, INC; 2850 frontier drive; warsaw IN 46582
• MDR Report Key: 7651938
• MDR Text Key: 112784806
• Report Number: 3006460162-2018-00046
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 0084113211102
• UDI-Public: (01)0084113211102(10)162818-J
• Combination Product (y/n): N
• PMA/PMN Number: K100240
• 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: 11/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• 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: 00-0903-2650
• Device Lot Number: 162818-J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Required Intervention
• Patient Age: 14 YR
• Patient Weight: 45