MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM LCP PROXIMAL TIBIA PLATE 10 HOLES/190MM-RIGHT; PLATE, FIXATION, BONE

Model Number	240.042
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); 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.(b)(4).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.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 revision procedure due to non-union and delayed healing secondary to a broken locking compression plate (lcp) proximal tibia plate.During the revision procedure all the original implants which consist of 1lcp tibia plate, 3 5.0mm locking screws, 6 4.5mm cortex screws and 2 cancellous screws were all removed then the patient was revised to tibial nail ex.There were fragments generated but were removed easily.The procedure was successfully completed with minimal delay.Patient status was good.Concomitant device reported: unknown 5.0mm locking screws (part # unknown, lot # unknown, quantity 3), unknown 4.5mm cortex screws (part # unknown, lot # unknown, quantity 6), unknown cancellous screws (part # unknown, lot # unknown, quantity 2).This report is for 1 4.5mm lcp proximal tibia plate 10 holes/190mm-right this is report 1 of 1 for complaint (b)(4).

• Brand Name: 4.5MM LCP PROXIMAL TIBIA PLATE 10 HOLES/190MM-RIGHT
• 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: 10323119
• Report Number: 2939274-2020-03299
• Device Sequence Number: 2679283
• Product Code: HRS
• UDI-Device Identifier: 10886982164551
• UDI-Public: (01)10886982164551
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K052390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/06/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 240.042
• Device Catalogue Number: 240.042
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2020
• Initial Report FDA Received Date: 07/24/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention