MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP 3.5MM LOCKING CORTICAL SCREW WITH T15 HEX, SIZE 60MM; SCREW, FIXATION, BONE

Model Number N/A

Device Problem Unintended Movement (3026)

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

Event Date 11/22/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products - catalog number: 00-0903-2618, 3.5mm locking cortical screw with t15 hex, size 18mm, lot number: unknown.Catalog number: 00-0903-2655, 3.5mm locking cortical screw with t15 hex, size 55mm, lot number: unknown.Foreign source - (b)(4).Customer has indicated that the product will not be returned to orthopediatrics for investigation as is remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3006460162-2018-00004 and 3006460162-2018-00006.

Event Description

It has been reported that during a corrective proximal femoral osteotomy procedure, three proximal locking screws were found to have backed out at the end of surgery during the final x-ray check.The patient had to be repositioned onto their side during the procedure due to unknown intra operative issues.Solid screws were used due to the patient's poor bone quality.The surgeon claims that she changed the angle of the screw to that of the guide wire and as a result did not engage the screw into the plate correctly.The patient was re-opened at the end of the procedure to re-tighten the screws.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: 3.5MM LOCKING CORTICAL SCREW WITH T15 HEX, SIZE 60MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): ORTHOPEDIATRICS, CORP; 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: 7187948
• MDR Text Key: 97273180
• Report Number: 3006460162-2018-00005
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 00084113211108
• UDI-Public: 0084113211108
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K100240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• 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: 00-0903-2660
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/15/2017
• 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): Hospitalization; Required Intervention