MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.5MM CANNULATED SCREW 16MM THREAD 100MM; SCREW, FIXATION, BONE

Model Number	208.415
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 on an unknown date the patient had three (3) 6.5mm cannulated screws place in the femoral neck for fixation due to a fracture.The original surgery was performed in a different state so details of the original incident are minimal.The patient healed completely but is very thin and had pain caused by the heads of the screws when laying on his side.Due to the complete healing, the surgeon felt it appropriate to remove the no longer needed screws to improve patient comfort.The revision surgery was performed on (b)(6) 2021.This report is for one (1) 6.5mm cannulated screw 16mm thread 100mm.This is report 1 of 3 for (b)(4).

• Brand Name: 6.5MM CANNULATED SCREW 16MM THREAD 100MM
• 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: 11398407
• Report Number: 2939274-2021-01114
• Device Sequence Number: 13744810
• Product Code: HWC
• UDI-Device Identifier: 10886982149220
• UDI-Public: 10886982149220
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K021932
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/05/2021

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: 208.415
• Device Catalogue Number: 208.415
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 03/02/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention