MAUDE Adverse Event Report: ORTHOPEDIATRICS, INC PEDILOC 4.5MM LOCKING CORTICAL SCREW SIZE 48MM

Catalog Number 00-1050-4648

Device Problem Migration (4003)

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

Event Date 01/25/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant device: item number: 00-1050-4206, 4.5 mm contour locking compression femur 6 hole plate right, lot number: 18218-o; item number: 00-1050-4665, 4.5mm locking cortical screw size 65mm, lot number: 88732; item number: 00-1050-4665, 4.5mm locking cortical screw size 65mm, lot number: i01rp; item number: 00-1050-4640, 4.5mm locking cortical screw size 40mm, lot number: i0rc; item number: 00-1050-4660, 4.5mm locking cortical screw size 60mm, lot number: i06g8-e; item number: 00-1050-4638, 4.5mm locking cortical screw size 38mm, lot number: 79229-e.X-rays were provided and confirmed the reported malfunction.A visual analysis of the returned device found damaged threads on the shaft body of the screws and plate.This finding does not contribute to the cause of the event as it likely occurred post screw back out.A review of the dhrs were reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no trends were identified.Root cause was unable to be determined.Multiple mdr reports were filed for this event, please see associated reports: 3006460162-2020-00008, 3006460162-2020- 000009, 3006460162-2020-000011, 3006460162-2020-000012 and 3006460162-2020-000013.

Event Description

It has been reported that following the implantation of a distal femoral osteotomy system, the screws were found to be dissociated.

• Brand Name: PEDILOC 4.5MM LOCKING CORTICAL SCREW SIZE 48MM
• Type of Device: SCREW
• Manufacturer (Section D): ORTHOPEDIATRICS, INC; 2850 frontier drive; warsaw IN 46582
• Manufacturer (Section G): ORTHOPEDIATRICS; 2850 frontier drive; warsaw IN 46582
• Manufacturer Contact: leigh jessop ; 2850 frontier drive; warsaw, IN 46582
• MDR Report Key: 9654232
• MDR Text Key: 177411255
• Report Number: 3006460162-2020-00010
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K083286
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/31/2020

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00-1050-4648
• Device Lot Number: 77993-E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2020
• Initial Date FDA Received: 01/31/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2017
• 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 Age: 22 YR
• Patient Weight: 95