MAUDE Adverse Event Report: ORTHOPEDIATRICS, INC 3.5MM SELF TAPPING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 22MM; SCREW, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant devices: item: 00-0903-2626, 3.5mm locking cortical screw with t15 hexalobe, size 26mm, lot: 171334-j; item: 00-0907-3760, 3.5mm cannulated locking screw, 60mm, lot: m72783-d; item: 00-0907-3760, 3.5mm cannulated locking screw, 60mm, lot: m72783-d; item: 00-0907-3755, 3.5mm cannulated locking screw, 55mm, lot: m70765-d; item: 00-0903-2528, 3.5mm self tapping cortical screw with t15 hexalobe, size 28mm, lot: 171316-j; item: 00-0903-2524, 3.5mm self tapping cortical screw with t15 hexalobe, size 24mm, lot: 178768-j; item: 00-0907-2104, 130° x 3.5mm lpf plate x 4 hole, lot: 046734-g.The customer has indicated that the product is in the process of returning to orthopediatrics for evaluation.Multiple mdr reports were filed for this event, please see associated report: 30064660162-2020-00045.
Event or Problem Description
It has been reported that during the planned removal of a locking proximal femur plate, two screws fractured.A delay greater than thirty minutes was noted.No patient consequences were reported as a result of this malfunction.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: date of this report: 5/15/2020.Type of report: follow-up.Type of follow-up: additional information, device evaluation.Device evaluated: yes.Device manufacture date: 12-jan-2018.Event problem and evaluation codes: method code(s): 3331 - 10 - 4110; result code(s): 3252; conclusion code(s): 22 - 4315.Screw was evaluated and the reported fracture was confirmed.A dhr review was conducted and no manufacturing discrepancies were identified.A review of the applicable risk management file was conducted and identified bending and or fracturing post-operatively.This risk falls within the acceptance criteria.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Orthopediatrics will continue to monitor for trends.

• Brand Name: 3.5MM SELF TAPPING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 22MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ORTHOPEDIATRICS, INC; 2850 frontier drive; warsaw, in
• MDR Report Key: 9860988
• Report Number: 3006460162-2020-00046
• Device Sequence Number: 3307772
• Product Code: HWC
• UDI-Device Identifier: 00841132110485
• UDI-Public: (01)00841132110485(10)178767-J
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K100240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2020

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: 00-0903-2522
• Device Lot Number: 178767-J
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 03/20/2020
• Supplement Report FDA Received Date: 05/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 9 YR
• Patient Weight: 33