MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC BOLT FOR FEMORAL NECK SYS 80 LENGTH-SILE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	04.168.280S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review investigation, but has yet to be received.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), 2021, the patient underwent a revision to long titanium trochanteric fixation nail (tfn).The surgeon removed bilateral femoral neck systems due to stress risers at the level of the shaft screw.The femoral neck systems were implanted about a year and half ago, and they were removed and replaced with long tfn¿s.On the left side, the shaft screw would not come out, so the surgeon had to cut the plate just proximal to the shaft screw.The right side came out easily.Procedure was completed successfully without any surgical delay.Patient status is unknown.This report captures the post-op event of revision due to stress risers at the level of the shaft screw, while related complaint (b)(4) reports the intra-op event of the shaft screw that would not come out, so the surgeon had to cut the plate.This report is for one (1) bolt for femoral neck sys 80 length-sile.This is report 2 of 6 for complaint (b)(4).

• Brand Name: BOLT FOR FEMORAL NECK SYS 80 LENGTH-SILE
• 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: 11572292
• Report Number: 2939274-2021-01530
• Device Sequence Number: 4266091
• Product Code: KTT
• UDI-Device Identifier: 10886982274724
• UDI-Public: (01)10886982274724
• 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 Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/26/2021

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: 04.168.280S
• Device Catalogue Number: 04.168.280S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 03/25/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention