MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 6 HOLES/69MM; PLATE, FIXATION, BONE

Model Number	241.361
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional patient identifier: (b)(6).Date of infection is not known.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 the patient underwent a revision procedure on (b)(6) 2017 due to an infection.The patient¿s initial injury was an open dislocated ankle fracture with a broken fibula.On (b)(6) 2016, patient received an open reduction internal fixation (orif) and was implanted with one (1) locking compression plate (lcp) one-third tubular plate and six (6) unknown screws, as well as an irrigation and debridement (i&d).The patient had a slow healing medial wound from the initial injury and refused subsequent necessary wound i&d's, then presented with infected wound and complete erosion of the tibial talar joint.The fibula had healed from the initial orif surgery on (b)(6) 2016.For the revision surgery, an osteotomy was performed with a removal of the distal third fibula, and debridement with fusion of tibial talar joint using 6.5 mm cannulated screws.Hardware remained with removed portion.There was no surgical delay and the procedure was completed successfully.Patient outcome reported as complete/okay.This is report 1 of 2 for pc-(b)(4).

• Brand Name: LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 6 HOLES/69MM
• 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: 7160441
• Report Number: 2939274-2018-50037
• Device Sequence Number: 13947801
• Product Code: HRS
• UDI-Device Identifier: 10886982166876
• UDI-Public: (01)10886982166876(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K011335
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 12/06/2017

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: 241.361
• Device Catalogue Number: 241.361
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/06/2017
• Initial Report FDA Received Date: 01/03/2018
• 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: 59 YR
• Patient Weight: 118