MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 10 HOLES/117MM; PLATE, FIXATION, BONE

Model Number	241.401
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
Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 on an unknown date, there was a removal of one (1) lcp 1/3 tubular plate collar 10 hole and eight (8) unknown 3.5 cortical screws.The patient had an infection unrelated to the devices.Procedure outcome and patient status are unknown.This report is for one (1) lcp one-third tubular plate with collar 10 holes/117mm this is report 1 of 9 for (b)(4).

• Brand Name: LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 10 HOLES/117MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13891535
• Report Number: 2939274-2022-01031
• Device Sequence Number: 11191102
• Product Code: HRS
• UDI-Device Identifier: 10886982166951
• UDI-Public: (01)10886982166951
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 241.401
• Device Catalogue Number: 241.401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2022
• Initial Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: CORTICAL : TRAUMA; UNK - SCREWS: CORTICAL : TRAUMA; UNK - SCREWS: CORTICAL : TRAUMA; UNK - SCREWS: CORTICAL : TRAUMA; UNK - SCREWS: CORTICAL : TRAUMA; UNK - SCREWS: CORTICAL : TRAUMA; UNK - SCREWS: CORTICAL : TRAUMA; UNK - SCREWS: CORTICAL : TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown