MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 4.5MM CURVED BROAD LCP® PLATE 12 HOLES/229MM; PLATE, FIXATION, BONE

Model Number	226.622
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional narrative: unknown date in 2017.Additional product codes: hwc, ktt.Complainant part is not expected to be returned for manufacturer review/investigation.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 a revision surgery occurred on (b)(6) 2017 due to secondary fracture and fracture displacement of a distal femur fracture.The original surgery occurred on (b)(6) 2017 and was an open reduction and internal fixation periprosthetic femur fracture.A total knee with a non-synthes implant was occurred on (b)(6) 2017, when a fracture of the femur bone occurred during the implant of the total knee device.This intraoperative fracture was repaired with one (1) 12 hole-broad plate, six (6) 0.5mm locking screws and one (1) 4.5 cortex screws.Post-operatively on an unknown date the patient fell and it was determined that the femur fracture had re-fractured and become displaced.All synthes hardware was intact and removed successfully.The non-synthes implant was not removed.The patient was revised to a periprosthetic plate, two (2) locking attachment plates, and an unknown number of screws.No surgical delay was reported for the revision.Patient status is unknown.Concomitant devices: non-synthes implant (part unknown, lot unknown, quantity 1).This is report 1 of 3 for (b)(4).
Additional Manufacturer Narrative
Part 226.622, lot 9700231: manufacturing location: (b)(4).Release to warehouse date: october 27, 2015.No non-conformance reports 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: 4.5MM CURVED BROAD LCP® PLATE 12 HOLES/229MM
• 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: 7084360
• Report Number: 2939274-2017-50145
• Device Sequence Number: 1131280
• Product Code: HRS
• UDI-Device Identifier: 10886982159168
• UDI-Public: (01)10886982159168(10)9700231
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K082807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: 226.622
• Device Catalogue Number: 226.622
• Device Lot Number: 9700231
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/14/2017
• Supplement Date Received by Manufacturer: 12/20/2017
• Initial Report FDA Received Date: 12/05/2017
• Supplement Report FDA Received Date: 01/12/2018
• 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: 74 YR
• Patient Weight: 107