MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP LOCKING PROXIMAL FEMUR SYSTEM CORTICAL SCREWS; 4.5MM CANNULATED LOCKING CORTICAL SCREW, 70MM

Model Number	00-0907-4770
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices: 130 deg x 4.5mm plate, 3 hole, item number: 00-0907-2203 lot number: 052633-g 4.5mm non locking cortical screw full thread 28mm, item number: 00-0907-4528 lot number: 172162-f; 4.5mm non locking cortical screw full thread 28mm, item number: 00-0907-4528 lot number: 170677-f; 4.5mm non locking cortical screw full thread 28mm, item number: 00-0907-4528 lot number: 172162-f.Complaint sample was not returned for evaluation.Reported event was confirmed through radiographic images provided by the customer.Dhr was reviewed.No deviations or rework was reported.Risk management file review was deemed appropriate.Review of the complaint history determined that no further action is required as no trends were identified.Root cause is unknown but the patient's poor bone condition as noted by the surgeon could be a contributing factor.Multiple mdr reports were filed for this event, please see associated reports: 3006460612-2020-00018 reports the second loose screw, 4.5mm cannulated locking cortical screw, 70mm: item number; 00-0907-4570, lot number; 140107.3006460162-2020-00030 reports the broken screw left in the patient; 4.5mm cannulated locking screw, 65mm item number: 00-0907-4765 lot number: m93172-e.
Event or Problem Description
It was reported the patient underwent a revision surgery due to one broken screw and two screw backing out of the plate.These two loose screws were replaced during the revision surgery while the remaining screws and plate were not replaced.The fractured screw was left in the patient's bone.The surgeon noted the poor bone quality of the patient which caused some micro-movements.

• Brand Name: LOCKING PROXIMAL FEMUR SYSTEM CORTICAL SCREWS
• Common Device Name: 4.5MM CANNULATED LOCKING CORTICAL SCREW, 70MM
• Manufacturer (Section D): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw, in
• MDR Report Key: 9711446
• Report Number: 3006460162-2020-00017
• Device Sequence Number: 19733774
• Product Code: HWC
• UDI-Device Identifier: 00841132112199
• UDI-Public: (01)00841132112199(10)M48083
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/10/2020

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
• Operator of Device: Health Professional
• Device Model Number: 00-0907-4770
• Device Catalogue Number: 00-0907-4770
• Device Lot Number: M48083
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2019
• Initial Report FDA Received Date: 02/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention