MAUDE Adverse Event Report: ORTHOPEDIATRICS, INC 4.5MM CANNULATED SCREW, CANCELLOUS THREAD, 24MM; SCREW, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant device: item: 00-1015-8020, 4.5mm cannulated screw, cancellous thread, 20mm, lot: unknown.The customer has indicated that the device is being returned for evaluation.The investigation is underway.Multiple mdr reports were filed for this event, please see associated report: 3006460162-2020-00048.
Event or Problem Description
It has been reported that during a planned removal of cannulated screws, two screws fractured.No adverse events have been reported as a result of this malfunction.

• Brand Name: 4.5MM CANNULATED SCREW, CANCELLOUS THREAD, 24MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ORTHOPEDIATRICS, INC; 2850 frontier drive; warsaw, in
• MDR Report Key: 9884012
• Report Number: 3006460162-2020-00049
• Device Sequence Number: 19515018
• Product Code: HWC
• UDI-Device Identifier: 00841132144749
• UDI-Public: (01)00841132144749(10)174316-B
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00-1015-8024
• Device Lot Number: 174316-B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 03/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 14 YR
• Patient Weight: 90