MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM VA-LCP PROX TIBIA PLATE SMALL BEND/4H/87MM/LEFT; PLATE, FIXATION, BONE

Model Number	02.127.211
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Date of Event	01/01/2019
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.(b)(4).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) 2019, the patient underwent a removal of one (1) variable angle locking compression plate (va-lcp) proximal tibia plate and several unknown cortex and locking screws due to infection of the left knee area, open wound and exposed patella tendon.There were no issues removing the hardware and it is unknown how many screws were removed.After hardware was removed, the plan was to clean and debride the bone, the tissue and place antibiotic cement with a wound vac.No hardware was implanted.Original injury was a fracture to the left leg proximal tibia plateau.The injury occurred five (5) months prior (b)(6) 2019 with the unknown exact date.There was a patient consequence.This complaint involves an unknown number of devices.This report is for one (1) 3.5 mm va-lcp prox tibia plate small bend /4h/ 87 mm/ left.This is report 1 of 3 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Corrected data: awareness date reported on follow up 1 report as november 22, 2019 but should have been december 06, 2019.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.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Explantation date updated.Received by manufacturer: date updated.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.

• Brand Name: 3.5MM VA-LCP PROX TIBIA PLATE SMALL BEND/4H/87MM/LEFT
• 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: 9416732
• Report Number: 2939274-2019-62508
• Device Sequence Number: 19260376
• Product Code: HRS
• UDI-Device Identifier: 10886982043481
• UDI-Public: (01)10886982043481
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K120689
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/15/2019

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: 02.127.211
• Device Catalogue Number: 02.127.211
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/15/2019
• Supplement Date Received by Manufacturer: 11/22/2019; 12/31/2019
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 12/30/2019; 12/31/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Weight: 75