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

Device Problems Entrapment of Device (1212); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2019

Event Type  malfunction  

Manufacturer Narrative

This report is for two (2) unknown 2.7mm va locking screws/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Implanted in 2015; exact date is unknown.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.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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 a patient underwent initial surgery in 2015 to treat distal tibia fracture.Hardware removal procedure was done on (b)(6) 2019 due to pain on anterior side.During the hardware removal procedure, the variable angle anterolateral distal tibia plate and screws were difficult to remove and two (2) of the 2.7 screws were broken and remained in the patient.The implants removed were one (1) variable angle anterolateral distal tibia plate, four (4) 3.5 cortex screws, one (1) 3.5 va locking screws and five (5) 2.7 va locking screws.All bones healed and no sign of any infection.It was unknown if there was a surgical delay.Procedure and patient outcome were unknown.This report captures intraoperative issue of difficulty in hardware removal, while related complaint (b)(4) captures removal due to postop pain.This report is for two (2) unknown 2.7mm va locking screws.This is report 5 of 5 for complaint (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: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8392647
• MDR Text Key: 137939596
• Report Number: 2939274-2019-56829
• 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: Physician
• Type of Report: Initial
• Report Date: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: No
• 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: 02/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1