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

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

Patient Problems Unspecified Infection (1930); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

Patient weight is unknown.Date of event: unknown.This report is for an unknown variable angle locking compression plate/unknown lot.Part and lot number are unknown; udi number is unknown.Implant date: unknown.Complainant part is not expected to be returned for manufacturer review/investigation, as it 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 was revised on (b)(6) 2018 due to a possible infection or an allergic reaction.The patient was originally implanted with what appeared to be one variable angle locking compression plate and an unknown number of screws in the fibula on an unknown date.On (b)(6) 2018 the plate and an unknown number of 2.7 mm variable angle locking screws, 2.7 variable angle cortical screws and an unknown number of 3.5 mm cortical screws were removed intact.The devices were easily removed with no additional medical intervention, without surgical delays or patient harm, and without any intraoperative events or device malfunctions.The patient was reported to be healed so no additional devices were implanted.The explanted devices were discarded.This report is for an unknown variable angle locking compression plate.This is report 1 of 4 for (b)(4).

• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7486682
• MDR Text Key: 107342957
• Report Number: 2939274-2018-52012
• Device Sequence Number: 1
• Product Code: HRS
• 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: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2018
• 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: 45 YR