MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM LCP® CURVED CONDYLAR PLATE 12 HOLES/278MM-RIGHT; APPLIANCE,FIXATION,NAIL

Model Number	02.001.322
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information is not available for reporting.Plate broke approximately nine (9) months post-operatively; exact date is unknown.Implanted approximately 9 months prior to plate breakage; exact date is unknown.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that during an unknown surgical procedure a patient received a 4.5mm locking compression plate (lcp) condylar plate on an unknown date.Patient experienced periprosthetic mid shaft femur fracture between a prosthetic hip and knee due to the plate breaking approximately nine (9) months post-operatively.The patient was not revised.Surgeon feels strongly that this is all related to patient¿s age (biologically unable to heal properly).This report is for one (1) 4.5mm lcp® curved condylar plate 12 holes/278mm-right.(b)(4).

• Brand Name: 4.5MM LCP® CURVED CONDYLAR PLATE 12 HOLES/278MM-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: 7207151
• Report Number: 2939274-2018-50330
• Device Sequence Number: 917885
• Product Code: KTT
• UDI-Device Identifier: 10886982027672
• UDI-Public: (01)10886982027672(10)LOTNUMBERUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K041911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/28/2017

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: 02.001.322
• Device Catalogue Number: 02.001.322
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/28/2017
• Initial Report FDA Received Date: 01/19/2018
• 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