MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RFNA / 10MM / 300MM 5 DEGREE BEND / STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.233.030S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional narrative: only event year is known.Additional device product codes: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.Investigation summary: the complaint device (rfna / 10 / 300 5 deg bend / sterile) was not received for investigation.A photo investigation was performed.The x-ray was reviewed, and the complaint condition can be confirmed.After review of the x-ray provided, a fracture of the rfna nail.Additionally, two locking screws are present in the provided x-ray.A manufacturing record evaluation cannot be performed due to lot number being unknown.This complaint is confirmed as a photo inspection does show the rfna fracture.A definite assignable root cause could not be determined based on the provided information.As the device was not returned, and as-received condition could not be assessed and a dimensional inspection and document/specification review were not completed.No dhr review was completed since no lot number was supplied via photo or additional information.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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 patient a had distal femur fracture.The nail was implanted approximately 14 weeks ago, in mid-september.It appears that the nail broke through the most distal of the proximal ap locking screw holes.Patient underwent a removal of the hardware and re-insertion of new rfna in (b)(6) 2022.This report involves one (1) rfna / 10mm / 300mm 5 degree bend / sterile.This is report 1 of 1 for pc-(b)(4).

• Brand Name: RFNA / 10MM / 300MM 5 DEGREE BEND / STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13513642
• Report Number: 2939274-2022-00422
• Device Sequence Number: 4158483
• Product Code: HSB
• UDI-Device Identifier: 10886982289117
• UDI-Public: (01)10886982289117
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K201346
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 04.233.030S
• Device Catalogue Number: 04.233.030S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2022
• Initial Report FDA Received Date: 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown