MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM VA LOCKING SCREW STARDRIVE 10MM; SCREW,FIXATION,BONE

Model Number	02.210.110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code: hrs.Reporter is company representative.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 product was received; no conclusion could be drawn at the time of filing this report.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 an unknown date, the patient had a contact dermatitis due to an allergic reaction.Initially, the patient was implanted with a variable angle (va) locking compression plate (lcp) distal radius system on an unknown date.The patient is now taking steroids for contact dermatitis and does not require revision surgery.This complaint involves five (5) devices.This is 2 of 5 for report (b)(4).

• Brand Name: 2.4MM VA LOCKING SCREW STARDRIVE 10MM
• 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: 9856822
• Report Number: 2939274-2020-01384
• Device Sequence Number: 16932404
• Product Code: HWC
• UDI-Device Identifier: 10886982052858
• UDI-Public: (01)10886982052858
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103243
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/21/2020

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: 02.210.110
• Device Catalogue Number: 02.210.110
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 03/19/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention