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

Model Number	04.168.280S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.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 conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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 the patient underwent revision surgery of the femoral neck system due to cut out on (b)(6) 2021.Converting to a hemiarthroplasty.Procedure outcome was unknown, and patient has consequences.This complaint involves three (3) devices.This report is for (1) bolt for femoral neck sys 80 length-sile this report is 2 of 3 for (b)(4).

• Brand Name: BOLT FOR FEMORAL NECK SYS 80 LENGTH-SILE
• 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: 11932244
• Report Number: 2939274-2021-02757
• Device Sequence Number: 3831754
• Product Code: KTT
• UDI-Device Identifier: 10886982274724
• UDI-Public: 10886982274724
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K172872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 05/10/2021

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?: Yes
• 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: 05/10/2021
• Initial Report FDA Received Date: 06/03/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention