MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP POSTERIOR DISTAL TIBIA T-PLATE/8 HOLE/132MM; PLATE, FIXATION, BONE

Model Number	02.112.208
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Unknown when infection or non-union began.(b)(4), unknown lot.Original implant date was sometime in (b)(6) 2017.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).No lot number was provided, without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.Investigation summary: 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.
Event or Problem Description
It was reported that a patient was seen in clinic on (b)(6) 2018 for infected nonunion of hardware.There is a planned surgery on (b)(6) 2018.Revision surgery took place on (b)(6) 2018.Initially the patient had a motorcycle accident and he underwent a surgery at an outside hospital for open distal tibia fracture and pelvis fracture on (b)(6) 2017.Pelvis was exfixed along with tibia exfix and debridement.On (b)(6) 2017 tibia debridement and orif pubic symphysis was done.Again on (b)(6) 2017, (b)(6) 2017, (b)(6) 2017, (b)(6) 2017, (b)(6) 2017 and (b)(6) 2017 tibia debridement was done.On (b)(6) 2017, orif of distal tibia and cross flap graft from right leg was done and the legs were exfixed together.The exfix was removed approximately 2-3 weeks later.The patient was then implanted with one lcp one-third tubular plate with collar 8 holes/93mm, one 3.5mm lcp posterior distal tibia t-plate/8 hole/132mm and seventeen unknown screws on an unknown date in (b)(6) 2017.During the revision surgery on (b)(6) 2018 for infected non-union of this implanted hardware, the patient received a left below the knee amputation.Since the lower leg was amputated, all the devices remained intact with the amputated portion.The patient was ok after the surgery and the procedure was completed.No reported delay in the surgery.This complaint involves three (3) devices.(b)(4).

• Brand Name: 3.5MM LCP POSTERIOR DISTAL TIBIA T-PLATE/8 HOLE/132MM
• 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: 7340324
• Report Number: 2939274-2018-51063
• Device Sequence Number: 16472095
• Product Code: HRS
• UDI-Device Identifier: 10886982034410
• UDI-Public: (01)10886982034410(10)UNKNOWNLOT
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2018

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: 02.112.208
• Device Catalogue Number: 02.112.208
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/13/2018
• Initial Report FDA Received Date: 03/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Weight: 64