MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI LCP(TM) DISTAL FEMUR PLATE 7 HOLES/196MM-LEFT; PLATE,FIXATION,BONE

Model Number	422.253
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not expected to be returned for manufacturer review/investigation.Patient code (b)(4) used to capture additional medical/surgical intervention required.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review is pending completion.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 the patient underwent hardware removal and revision of a distal femoral shaft on (b)(6) 2018 due to non-union.The removed hardware included a 7-hole less invasive stabilization system (liss) plate and seven (7) locking screws.Liss plate was removed so that a new plate can be placed on the lateral side for the revision.The original implant date is unknown.All the devices were removed intact.The procedure was completed successfully.There was no surgical delay.Patient outcome is unknown.This report is for one (1) ti lcp(tm) distal femur plate 7 holes/196mm-left.This is report 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Additional narrative: a device history record (dhr) review was performed for part no.: 422.253, lot no.: l128290: manufacturing location: (b)(4), release to warehouse date: 13.Sep.2016: no non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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.

• Brand Name: TI LCP(TM) DISTAL FEMUR PLATE 7 HOLES/196MM-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: 7547214
• Report Number: 2939274-2018-52262
• Device Sequence Number: 19298493
• Product Code: HRS
• UDI-Device Identifier: 10886982215383
• UDI-Public: (01)10886982215383
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K062564
• 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,Followup
• Report Date (Section B): 05/02/2018

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: 422.253
• Device Catalogue Number: 422.253
• Device Lot Number: L128290
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/02/2018
• Supplement Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 05/27/2018
• Supplement Report FDA Received Date: 06/19/2018
• 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: 54 YR
• Patient Weight: 146