MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; SCREW, FIXATION, BONE

Device Problem Unintended Movement (3026)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Date of event: date of screw loosening and pain is unknown.This report is for an unknown 3.5 cortex screw/unknown lot.Part and lot number are unknown; udi number is unknown.Implanted date: unknown.Complainant part is not expected to be returned for manufacturer review/investigation; the device was reportedly discarded.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a patient underwent removal of one (1) unknown 3.5 cortex (lag) screw from the distal portion of their tibia because of loosening of the screw and pain.The unknown cortex screw was not a part of any construct and was present as a standalone screw in the patient's tibia.The surgeon was not sure why the screw was implanted into the patient.This cortex screw was present in the tibia just distal to an unknown tibial nail construct, however was not touching it.It is unknown as to when the tibial nail construct and the unknown cortex screw were implanted, and if they were implanted together.The patient presented to the surgeon with pain, and subsequently the surgeon realized that the cortex screw was loose and has elected to remove the screw.The removal procedure was completed successfully by the surgeon, leaving the tibial nail construct behind.There were no complications or surgical delays during this procedure.Two x-rays were taken during the procedure, one initially to locate the loose cortex screw, and second at the end of the procedure to check if everything went well.The patient was reported to be in stable condition at the end of the procedure.This report is for an unknown 3.5 cortex screw.This is report 1 of 1 for (b)(4).

• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7421297
• MDR Text Key: 105148088
• Report Number: 2939274-2018-51576
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 59