MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM CORTEX SCREW SELF-TAPPING 20MM; APPLIANCE,FIXATION,NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT

Model Number 202.820

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Additional product code: hwc.Complainant part is not expected to be returned for manufacturer review/ investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that on (b)(6) 2021, the patient underwent for a removal surgery.During the surgery, all devices were intact, no items were broken, and were removed successfully and without difficulty.Originally, the patient underwent for removal hardware of a left tibial shaft fracture for infection on (b)(6) 2020.The current removal surgery was completed successfully without any delay.The patient was fin postoperatively.This complaint involves thirteen (13) devices.This report is for (1) 2.7mm cortex screw self-tapping 20mm.This report is 9 of 13 for (b)(4).

• Brand Name: 2.7MM CORTEX SCREW SELF-TAPPING 20MM
• Type of Device: APPLIANCE,FIXATION,NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12356594
• MDR Text Key: 267822804
• Report Number: 2939274-2021-04828
• Device Sequence Number: 1
• Product Code: KTW
• UDI-Device Identifier: 10886982144768
• UDI-Public: (01)10886982144768
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112583
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 202.820
• Device Catalogue Number: 202.820
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 81