MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC BOLT FOR FEMORAL NECK SYSTEM 95MM LENGTH-STERILE; APPLIANCE,FIXATION,NAIL

Model Number	04.168.295S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event occurred on an unknown date in 2020.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 (b)(6) 2020, a hardware removal and open reduction internal fixation (orif) with an intramedullary nail was performed due to sub-trochanteric femur fracture.The patient originally underwent surgery for displaced femoral neck fracture on (b)(6) 2020.At that time, the patient was treated with a femoral neck system.Patient subsequently slipped and fell at home on (b)(6) 2020 and sustained a comminuted sub-trochanteric femur fracture.The fns hardware was removed and the patient was implanted with femoral recon nail.This report is for one (1) bolt for femoral neck system 95mm length-sterile.This is report 2 of 5 for (b)(4).

• Brand Name: BOLT FOR FEMORAL NECK SYSTEM 95MM LENGTH-STERILE
• 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: 11195058
• Report Number: 2939274-2021-00366
• Device Sequence Number: 13644913
• Product Code: KTT
• UDI-Device Identifier: 10886982274755
• UDI-Public: 10886982274755
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K172872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/22/2020

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: 04.168.295S
• Device Catalogue Number: 04.168.295S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2020
• Initial Report FDA Received Date: 01/19/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5.0MM TI LOCKING SCR SLF-TPNG WITH T25 STARDRIVE; 5.0MM TI LOCKING SCR SLF-TPNG WITH T25 STARDRIVE; ANTIROTATION SCREW FOR FEMORAL NECK SYS 95MM; FEMORAL NECK SYSTEM PLATE 2 HOLE - STERILE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 14 YR
• Patient Weight: 154