MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM CORTEX SCREW SELF-TAPPING 36MM; APPLIANCE,FIXATION,NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT

Model Number 202.836

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, dzl.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 (13) devices.This report is for (1) 2.7mm cortex screw self-tapping 36mm.This report is 11 of 13 for (b)(4).

• Brand Name: 2.7MM CORTEX SCREW SELF-TAPPING 36MM
• 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
• MDR Report Key: 12356635
• MDR Text Key: 267822260
• Report Number: 2939274-2021-04831
• Device Sequence Number: 1
• Product Code: KTW
• UDI-Device Identifier: 10886982144843
• UDI-Public: (01)10886982144843
• Combination Product (y/n): N
• PMA/PMN Number: K112583
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/27/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: 202.836
• Device Catalogue Number: 202.836
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/27/2021
• Initial Date FDA Received: 08/23/2021
• Supplement Dates Manufacturer Received: 09/24/2021
• Supplement Dates FDA Received: 09/24/2021
• Patient Sequence Number: 1
• Treatment: 10 TI CANN TIB NAIL-EX PROX BEND 360-S.; 2.7MM CORTEX SCREW SELF-TAPPING 20MM.; 2.7MM CORTEX SCREW SELF-TAPPING 28MM.; 2.7MM CORTEX SCREW SELF-TAPPING 38MM.; 5.0 TI LCKNG SCR T25 SD 38 FOR IM NAILS.; 5.0 TI LCKNG SCR T25 SD 40 FOR IM NAILS.; 5.0 TI LCKNG SCR T25 SD 44 FOR IM NAILS.; 5.0 TI LCKNG SCR T25 SD 46 FOR IM NAILS.; 5.0 TI LCKNG SCR T25 SD 48 FOR IM NAILS.
• Patient Outcome(s): Required Intervention
• Patient Weight: 81