MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; PLATE, FIXATION, BONE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Swelling (2091); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is for an unknown plate/unknown lot number.Without the specific part number, the udi number and 510k number is unknown.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 as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.Investigation summary, 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.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.Mw5093007-2020_15-41-45.Pdf].

Event Description

This report is against user facility medwatch number mw5093007.The only information contained in this report is correction or additional information.Patient reported complaint: it was reported that on (b)(6) 2009, the patient underwent an unknown procedure to fix the broken arm, humerus bone.The patient was implanted with an unknown plate and screws.The patient was diagnosed in 2015 with pyoderma gangrenosum by a dermatologist due to pus and swelling.She was put on doxycycline and steroid shot.Accordingly, the doctor mentioned that it was probably a bacteria in the screws.This has been going from 2014-2019.Concomitant med products: unk - screws: trauma.Unk plates.This complaint involves five (5) unknown screws trauma.This report is 2 of 5 for (b)(4).

• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9899364
• MDR Text Key: 196573381
• Report Number: 2939274-2020-01599
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention