MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM CORTEX SCREW SELF-TAPPING 22MM; SCREW, FIXATION, BONE

Model Number	204.822
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Rash (2033); Skin Irritation (2076)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product codes: hrs, jds.Device was not explanted.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 patient was implanted with a locking compression plate (lcp) 8 hole plate, five (5) cortex screws, two (2) cannulated screws, and one (1) cancellous bone screw on (b)(6) 2017 for repair of a broken right tibia and fibula.Surgery was completed successfully.In (b)(6) 2017, patient reports skin issues.In (b)(6) 2018, patient reports both legs from knee to foot, foot and hands, had a rash and skin irritation.Patient was referred to a dermatologist in (b)(6) 2018.Dermatologist determined patient is allergic to the implanted devices.This report is for one (1) 3.5mm cortex screw.This is report 2 of 9 for (b)(4).

• Brand Name: 3.5MM CORTEX SCREW SELF-TAPPING 22MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8037848
• Report Number: 2939274-2018-54778
• Device Sequence Number: 1187823
• Product Code: HWC
• UDI-Device Identifier: 10886982146298
• UDI-Public: (01)10886982146298
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K131186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/19/2018

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: 204.822
• Device Catalogue Number: 204.822
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2018
• Initial Report FDA Received Date: 11/05/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Weight: 126