MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 5 HOLES/57MM; PLATE,FIXATION,BONE

Model Number	241.351
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Ulcer (2274); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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: 3.5mm lcp distal tibia t-plate 3 hole/64mm (part number 02.112.203, 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).(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) lcp one-third tubular plate with collar 5 holes/57mm.This is report 1 of 10 for (b)(4).

• Brand Name: LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 5 HOLES/57MM
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10233169
• Report Number: 2939274-2020-03077
• Device Sequence Number: 16750667
• Product Code: HRS
• UDI-Device Identifier: 10886982166852
• UDI-Public: (01)10886982166852
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K011335
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 241.351
• Device Catalogue Number: 241.351
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2020
• Initial Report FDA Received Date: 07/06/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL; 3.5MM LCP DISTAL TIBIA T-PLATE 3; UNK - SCREWS: CORTEX; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention