MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM CORTEX SCREW SELF-TAPPING 18MM; SCREW FIXATION INTRAOSSEOUS

Model Number 202.818

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

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Product complaint # : (b)(4).Additional product code : hwc ktw.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 conclusion could be drawn at the time of filing this report.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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, four (4) 2.7mm cortex screw self-tapping 16mm, two (2) 2.7mm cortex screw-tapping 18mm and one (1) 2.7mm lc-dcp plate 6 holes were removed due to pain.No fragments generated.There was no surgical delay.The procedure successfully completed.The patient outcome was unknown.This complaint seven (7) devices.This report is for (1) 2.7mm cortex screw self-tapping 18mm.This report is 2 of 7 (b)(4).

• Brand Name: 2.7MM CORTEX SCREW SELF-TAPPING 18MM
• Type of Device: SCREW FIXATION INTRAOSSEOUS
• 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: 11709164
• MDR Text Key: 261521569
• Report Number: 2939274-2021-02019
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 10886982144751
• UDI-Public: (01)10886982144751
• 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: 03/29/2021

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: 202.818
• Device Catalogue Number: 202.818
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2021
• Initial Date FDA Received: 04/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR