MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4/2.7MM VA-LCP FIRST MTP FUSION PL/REV/0 DEG/RIGHT; PLATE,FIXATION,BONE

Model Number	02.211.244
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
(b)(6).Additional classification code: hwc.Date of event is unknown.Implant date unknown.It occurred in (b)(6) 2018.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 manufacture date is unknown.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 a patient was implanted with a 2.4 mm/2.7 mm variable angle (va) locking plate and eighteen (18) unknown 2.7 mm locking screws on an unknown date in (b)(6) 2018 to treat a patella fracture.On (b)(6) 2018, the patient was returned to the operating room to remove the implanted devices due to failure of the skin graft and an infection.The procedure was completed successfully without any delays.Patient outcome was satisfactory.This is report 1 of 2 for (b)(4).
Additional Manufacturer Narrative
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 a patient was implanted with a 2.4mm/2.7mm variable angle (va) locking plate and eighteen (18) unknown 2.7mm locking screws on an unknown date in (b)(6) 2018 to treat a patella fracture.On (b)(6) 2018, the patient was returned to the operating room to remove the implanted devices due to failure of the skin graft and an infection.The procedure was completed successfully without any delays.Patient outcome was satisfactory.After the infection had healed, patient was again returned to surgery on (b)(6) 2018 where surgeon performed the revision.Patient was revised to another 2.4mm/2.7mm va locking mesh plate, an unknown quantity of 2.7mm locking screw, and a skin flap.Surgery was completed successfully and patient outcome was again satisfactory.

• Brand Name: 2.4/2.7MM VA-LCP FIRST MTP FUSION PL/REV/0 DEG/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: 7436171
• Report Number: 2939274-2018-51764
• Device Sequence Number: 1095208
• Product Code: HRS
• UDI-Device Identifier: 10886982054388
• UDI-Public: (01)10886982054388
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K100776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2018

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: 02.211.244
• Device Catalogue Number: 02.211.244
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/28/2018
• Supplement Date Received by Manufacturer: 04/18/2018
• Initial Report FDA Received Date: 04/17/2018
• Supplement Report FDA Received Date: 05/08/2018
• 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: 68 YR
• Patient Weight: 74