MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP DISTAL TIBIA T-PLATE 3 HOLE/64MM; PLATE,FIXATION,BONE

Model Number 02.112.203

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

Patient Problems Unspecified Infection (1930); Ulcer (2274); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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.(b)(4).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) 2020, the patient underwent a hardware removal of the locking compression plating system (lcp) of the distal tibia due to infection.Initially, the patient was implanted with an lcp system on (b)(6) 2018.The surgeon commented that the patient had developed skin ulcers early on, which caused infection from wearing his post-op boot too tight.The hardware was removed, and the removal surgery was completed.The patient is ok.Concomitant devices reported: lcp one-third tubular plate with collar 5 holes/57mm (part number 241.351, lot unknown, quantity 1); 2.7/3.5mm va-lcp anterolateral distal tibia pl/6 holes/left (part number 02.118.205, lot unknown, quantity 1); screws: locking (part number unknown, lot unknown, quantity 11); screws: cortex (part number unknown, lot unknown quantity 9).This product complaint, (b)(4), is related to (b)(4) and (b)(4).(b)(4)captures the 10 of 23 devices, (b)(4) captures the 10 of 23 devices, and (b)(4) captures the 3 of 23 devices.This report involves one (1) 3.5mm lcp distal tibia t-plate 3 hole/64mm.This is report 2 of 10 for (b)(4).

• Brand Name: 3.5MM LCP DISTAL TIBIA T-PLATE 3 HOLE/64MM
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10233231
• MDR Text Key: 197932286
• Report Number: 2939274-2020-03078
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982034373
• UDI-Public: (01)10886982034373
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080522
• 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: 06/22/2020

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: 02.112.203
• Device Catalogue Number: 02.112.203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2020
• Initial Date FDA Received: 07/06/2020
• 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
• Patient Outcome(s): Required Intervention