MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7/3.5MM VA-LCP MEDIAL DISTAL TIBIA PLATE/16 HOLES/RIGHT; PLATE, FIXATION, BONE

Model Number	02.118.014
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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 an unknown date, the patient underwent removal of hardware of the right tibia due to nonunion and possible infection.The 16 hole plate was removed with no difficulties.Four (4) of the 2.7mm variable angle (va) locking screws in the distal end of the plate were broken.These were trephined out and removed using conical extraction device from screw removal set.All hardware was removed successfully.The hardware consisted of one (1) 16 hole variable angle (va) locking compression plate (lcp) medial distal tibia plate, four (4) 2.7mm variable angle (va) locking screws, one (1) 3.5mm cortex screws, two (2) zimmer cannulated screws.Patient status was unknown.This is report 6 of 6 for complaint (b)(4).

• Brand Name: 2.7/3.5MM VA-LCP MEDIAL DISTAL TIBIA PLATE/16 HOLES/RIGHT
• 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: 9742225
• Report Number: 2939274-2020-01001
• Device Sequence Number: 2100500
• Product Code: HRS
• UDI-Device Identifier: 10886982037824
• UDI-Public: (01)10886982037824
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K120854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/27/2020

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: 02.118.014
• Device Catalogue Number: 02.118.014
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 02/21/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention