MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM VA-LOCKING CALCANEAL PLATE MEDIUM 64MM LEFT; PLATE, FIXATION, BONE

Model Number	02.211.403
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
Date of event is unknown.Lot number is unknown.Date of implantation and date of explantation are unknown.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 a patient had to undergo a hardware removal procedure on an unknown date due to infection.A plate, 9 va locking screws two (2) 6.5mm cannulated screws, and two (2) 13mm washers were removed during the procedure.It is unknown when and why the patient was originally implanted with these devices.All the devices were reported as easily removed with no issues.There were no reported patient consequences.This report is for a 2.7mm va-locking calcaneal plate medium 64mm left.This is report 1 of 4 for (b)(4).

• Brand Name: 2.7MM VA-LOCKING CALCANEAL PLATE MEDIUM 64MM 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: 7510383
• Report Number: 2939274-2018-52156
• Device Sequence Number: 1422371
• Product Code: HRS
• UDI-Device Identifier: 10886982054845
• UDI-Public: (01)10886982054845
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K131186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/23/2018

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: 02.211.403
• Device Catalogue Number: 02.211.403
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/24/2018
• Initial Report FDA Received Date: 05/14/2018
• 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: 36 YR
• Patient Weight: 65