MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM VA-LCP CURVED CONDYLAR PLATE/16 HOLE/336MM/RIGHT; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Model Number	02.124.416
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight is unknown.Additional product codes: hrs, hwc.Complainant part is not expected to be 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 patient underwent a revision surgery on open reduction internal fixation (orif) on right femur periprosthetic fracture due to nonunion/delayed healing and possible broken plate on (b)(6) 2018.During the procedure, the 16-hole 4.5 variable angle locking compression plate (va-lcp) curved condylar plate on the lateral side was confirmed for removal.On the medial side was a 4.5 narrow locking compression plate around 12-holes long.Surgeon removed all hardware and replaced the lateral side with a new 4.5 va-lcp curved condylar plate and an anterior broad 4.5 lcp plate.The procedure was completed successfully; the patient outcome was not reported.Concomitant devices reported: 4.5 narrow locking compression plate (part 214.621, lot unknown, quantity 1); screws (part/lot unknown, quantity unknown).This is report 1 of 1 for (b)(4).

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/16 HOLE/336MM/RIGHT
• Common Device Name: IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7568818
• Report Number: 2939274-2018-52402
• Device Sequence Number: 1524249
• Product Code: JDP
• UDI-Device Identifier: 10886982042934
• UDI-Public: (01)10886982042934
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K110354
• 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): 05/09/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02.124.416
• Device Catalogue Number: 02.124.416
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 06/05/2018
• 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: 64 YR