MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ANTIROTATION SCREW FOR FEMORAL NECK SYS 90MM LENGTH - STERILE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	04.168.490S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
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.(b)(4).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 femoral neck system implant had to be removed due to the surgeon converting to a total hip replacement.The original implantation was unknown.It is unknown if there was a surgical delay reported.The procedure and patient outcome were unknown.Concomitant devices reported: femoral neck system plate 1 hole ¿ sterile (part number 04.168.000s, lot unknown, quantity 1); bolt for femoral neck system 100mm length-sterile (part number 04.168.300s, lot unknown, quantity 1); 5.0mm ti locking scr slf-tpng with t25 stardrive recess 36mm (part number 412.212, lot unknown, quantity 1).This report involves one (1) antirotation screw for femoral neck sys 90mm length ¿ sterile.This is report 3 of 4 for (b)(4).

• Brand Name: ANTIROTATION SCREW FOR FEMORAL NECK SYS 90MM LENGTH - STERILE
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11102020
• Report Number: 2939274-2020-05812
• Device Sequence Number: 17178714
• Product Code: KTT
• UDI-Device Identifier: 10886982274601
• UDI-Public: (01)10886982274601
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K172872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 12/05/2020

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: 04.168.490S
• Device Catalogue Number: 04.168.490S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2020
• Initial Report FDA Received Date: 12/31/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5.0MM TI LOCKING SCR SLF-TPNG 36MM; BOLT FOR FEMORAL NECK SYSTEM 100MM; FEMORAL NECK SYSTEM PLATE 1 HOLE
• Outcome Attributed to Adverse Event: Required Intervention