MAUDE Adverse Event Report: SYNTHES (U.S.A.) LLC LCP; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number 236.506

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Pain (1994); Impaired Healing (2378); Tissue Breakdown (2681)

Event Date 04/11/2019

Event Type  Injury  

Event Description

Female patient presents to the office with increasing pain in her right elbow area.She has a known proximal ulnar shaft nonunion with failed hardware.X-rays reveal increasing displacement through the nonunion site with impending skin breakdown over the prominent part of the plate.Based on the findings the recommendation was made to proceed with hardware removal and repair of the nonunion.Risks, complications, and alternative of the procedure were discussed with the patient who signaled understanding and elects to proceed with the surgical repair.Pre-op dx: right painful proximal ulna shaft nonunion with failed olecranon plate.Post op dx: right painful proximal ulna shaft nonunion with failed olecranon plate.Procedure performed: right proximal ulna hardware removal.Right proximal ulna shaft nonunion repair with revision plating.

• Brand Name: LCP
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SYNTHES (U.S.A.) LLC; 1051 synthes ave; monument CO 80132
• MDR Report Key: 8581912
• MDR Text Key: 144135662
• Report Number: 8581912
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 236.506
• Device Catalogue Number: 236506
• Device Lot Number: 1148927MAY2016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/17/2019
• Event Location: Other
• Date Report to Manufacturer: 05/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 17885 DA
• Patient Weight: 74