MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC 4.5MM LCP PROXIMAL TIBIA PLATE 8 HOLES/154MM-LEFT; PLATE,FIXATION,BONE

Model Number	240.041
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information is unknown.It is unknown when the event occurred.This report is for a plate - unknown lot.Complainant part has not been returned for manufacturer review/investigation.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 or Problem Description
It was reported that a patient had a non union of a proximal third tibia fracture.The original implant date was about 10 years ago.The plate had three (3) 5.0mm locking screws and three (3) cannulated 5.0mm locking screws.Implants were removed without any major issue.The patient was placed with another synthes plate and vivigen bone graft.The surgery was completed successfully with no medical intervention needed.No surgical delay was noted no fragments were reported.This complaint involves two (2) device.This report is for one (1) plate.(b)(4).

• Brand Name: 4.5MM LCP PROXIMAL TIBIA PLATE 8 HOLES/154MM-LEFT
• 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: 7259090
• Report Number: 2939274-2018-50540
• Device Sequence Number: 1185655
• Product Code: HRS
• UDI-Device Identifier: 10886982164537
• UDI-Public: (01)10886982164537(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K052390
• 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): 01/17/2018

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: 240.041
• Device Catalogue Number: 240.041
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/17/2018
• Initial Report FDA Received Date: 02/09/2018
• 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