MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC BOLT FOR FEMORAL NECK SYSTEM 80MM LENGTH-STERILE; APPLIANCE,FIXATION,NAIL

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)
Date of Event	12/13/2020
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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(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 (b)(6) 2020, the patient underwent a removal and revision procedure of the femoral neck system (fns) devices due to a break below the fns plate secondary to fall.Initially, the patient was implanted with the original devices on (b)(6) 2020.It was mentioned that there was no hardware that was broken, just the bone around it.During the revision procedure, the fns implants were removed and the patient was revised to a trochanteric fixation nail advanced (tfna) device.The procedure was successfully completed.It is unknown if there was a surgical delay.Patient status is unknown.This complaint involves four (4) devices.This report is for (1) bolt for femoral neck system 80mm length-sterile.This report is 3 of 4 for (b)(4).

• Brand Name: BOLT FOR FEMORAL NECK SYSTEM 80MM 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: 11142461
• Report Number: 2939274-2021-00142
• Device Sequence Number: 3698186
• Product Code: KTT
• UDI-Device Identifier: 10886982274724
• UDI-Public: (01)10886982274724
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 12/13/2020

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: 04.168.280S
• Device Catalogue Number: 04.168.280S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2020
• Initial Report FDA Received Date: 01/08/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Weight: 48