MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM LCP® CURVED CONDYLAR PLATE 16 HOLES/350MM-RIGHT; APPLIANCE,FIXATION,NAIL

Model Number	02.001.326
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(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 an open reduction internal fixation (orif) surgery to remove and revise the broken locking compression plate (lcp) curved condylar plate and the twelve (12) screws.The plate and the 12 screws were removed completely with no difficulties.All 12 screws were removed intact.The right femur nonunion was repaired using a medullary nail and a lateral distal femur plate.The procedure and patient outcome were unknown.Concomitant device reported: unknown screws (part # unknown, lot # unknown quantity 12).This complaint involves one (1) device.This is report 1 of 1 for (b)(4).

• Brand Name: 4.5MM LCP® CURVED CONDYLAR PLATE 16 HOLES/350MM-RIGHT
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10014492
• Report Number: 2939274-2020-02147
• Device Sequence Number: 3071118
• Product Code: KTT
• UDI-Device Identifier: 10886982027719
• UDI-Public: (01)10886982027719
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K041911
• 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): 04/14/2020

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: 02.001.326
• Device Catalogue Number: 02.001.326
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2020
• Initial Report FDA Received Date: 04/30/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR