MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP METAPHYSEAL PLATE 11 HOLES; APPLIANCES,FIXATION,NAIL/BLD/PL COMBO,MULTI COMP, METAL COM

Model Number	223.411
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event occurred on an unknown date in 2020.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.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 that on (b)(6) 2021, the patient underwent a hardware removal with 3.5 lcp metaphyseal plate and 3.5 cortex screws in question.The patient had an initial procedure performed at an outside hospital in (b)(6) of 2020 for a humerus non-union.The patient was transferred to a surgeon on (b)(6) 2021 and upon laboratory diagnosis was determined to have an infection and the hardware was removed without issue on (b)(6) 2021.This report is for one (1) 3.5mm lcp® metaphyseal plate 11 holes.This is report 1 of 10 for (b)(4).

• Brand Name: 3.5MM LCP METAPHYSEAL PLATE 11 HOLES
• Common Device Name: APPLIANCES,FIXATION,NAIL/BLD/PL COMBO,MULTI COMP, METAL COM
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11244005
• Report Number: 2939274-2021-00521
• Device Sequence Number: 11744279
• Product Code: LXT
• UDI-Device Identifier: 10886982157638
• UDI-Public: 10886982157638
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K033805
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/07/2021

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: 223.411
• Device Catalogue Number: 223.411
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 01/28/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3.5MM CORTEX SCREW SELF-TAPPING 20MM; 3.5MM CORTEX SCREW SELF-TAPPING 20MM; 3.5MM CORTEX SCREW SELF-TAPPING 20MM; 3.5MM CORTEX SCREW SELF-TAPPING 26MM; 3.5MM CORTEX SCREW SELF-TAPPING 26MM; 3.5MM CORTEX SCREW SELF-TAPPING 28MM; 3.5MM CORTEX SCREW SELF-TAPPING 28MM; 3.5MM CORTEX SCREW SELF-TAPPING 28MM; 3.5MM CORTEX SCREW SELF-TAPPING 32MM; 3.5MM CORTEX SCREW SELF-TAPPING 32MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR