MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 35MM; APPLIANCE, FIXATION, NAIL

Model Number	212.114
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Reaction (2414)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is patient.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 on an unknown date, a patient fell resulting in a displaced right proximal humerus fracture.On (b)(6) 2009, the patient underwent an open treatment of right proximal humerus fracture with tuberosity repair.Plate and screws were implanted.After the procedure, the patient was experiencing medical device site reaction and was dealing with it for 5 years.The patient wanted the plate and screws to be removed.No further information provided.This report is for one (1) 3.5mm locking screw self tapping with stardrive recess 35mm.This is report 1 of 1 for complaint (b)(4).This complaint involves total 11 devices, remaining 10 devices are captured under related complaint.

• Brand Name: 3.5MM LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 35MM
• Common Device Name: APPLIANCE, FIXATION, NAIL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9859934
• Report Number: 2939274-2020-01398
• Device Sequence Number: 19499076
• Product Code: KTT
• UDI-Device Identifier: 10886982151889
• UDI-Public: (01)10886982151889
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K000684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/20/2020

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: 212.114
• Device Catalogue Number: 212.114
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 03/20/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention